Only 54% of UK 5-year-olds born with a cleft affecting the palate have speech comparable to their peers, and the figure falls to 24% for bilateral cleft lip and palate (CRANE Database, 2025 Annual Report). In the United States, cleft lip with or without cleft palate affects 1 in 1,032 births (National Birth Defects Prevention Network, Stallings et al. 2024), and a randomized trial showed that moving palate repair from 12 months to 6 months cut velopharyngeal insufficiency at age 5 from 15.0% to 8.9% (TOPS trial, NEJM 2023). Outside high-income systems, an estimated 616,655 clefts remain unrepaired across 113 low- and middle-income countries (Carlson et al., World Journal of Surgery 2016). We aggregated data from the CDC and the National Birth Defects Prevention Network, the UK Cleft Registry and Audit Network (CRANE), the TOPS trial, Global Burden of Disease 2021 analyses, Smile Train reports, and peer-reviewed systematic reviews. For the wider picture of childhood communication difficulties, see our roundup of pediatric speech delay and early intervention statistics.
TL;DR
- Cleft lip with or without cleft palate occurs in 9.69 per 10,000 US live births, or 1 in 1,032 (NBDPN, Stallings et al., Birth Defects Research 2024).
- In the UK, a cleft of any type affects 1 in 660 births (CRANE Database, 2025 Summary of Findings).
- 54% of UK 5-year-olds with a cleft affecting the palate met speech standard 1, speech comparable to peers (CRANE Database, 2025 Annual Report).
- Standard 1 was met by 69% with cleft palate alone, 44% with unilateral and 24% with bilateral cleft lip and palate (CRANE Database, 2025 Annual Report).
- Palate repair at 6 months versus 12 months: velopharyngeal insufficiency at age 5 in 8.9% versus 15.0%, risk ratio 0.59 (TOPS trial, NEJM 2023).
- 14% of UK children had secondary surgery for speech before age 5, with services ranging from 4% to 32% (CRANE Database, 2025 Annual Report).
- Pooled fistula incidence after primary palate repair is 8.6%, 95% CI 6.4 to 11.1 (Hardwicke et al., Plastic and Reconstructive Surgery 2014).
- 65.1% of US palate repairs in a national surgical registry fell within advised age periods (Koh et al., Journal of Craniofacial Surgery 2024).
- At age 1, a flat-line tympanogram in at least one ear was found in 69.7% of infants repaired at 6 months and 88.1% of the 12-month group (TOPS trial, NEJM 2023).
- 38% of 7,116 children with a cleft assessed by audiology in England had a hearing loss identified (CRANE Database, 2024 Annual Report).
- About 4.12 million people were living with an orofacial cleft in 2021, with 183,302 new cases that year (GBD 2021, Wang et al., Frontiers in Medicine 2025).
- An estimated 616,655 clefts were unrepaired across 113 low- and middle-income countries (Carlson et al., World Journal of Surgery 2016).
1. Birth Prevalence in the United States and Worldwide
Counting rules explain most of the apparent gap between countries. US surveillance reports cleft lip (with or without cleft palate) separately from cleft palate alone, while the UK registry quotes a single figure for every cleft type. Adding the two CDC figures together (1/1,031 + 1/1,563 = 0.00161, or roughly 1 in 621 births, our arithmetic and assuming the categories do not overlap) puts the US total in the same range as the UK’s 1 in 660 births.
The US rate is also edging down. Cleft lip with or without cleft palate was 10.47 per 10,000 live births in 1999-2001 and 9.69 in 2016-2020, although the confidence intervals of the last two periods overlap (NBDPN national estimates, Stallings et al. 2024). Globally, the WHO quotes a range instead of a point estimate and notes wide variation between studies and populations.
| Metric | Value | Source |
|---|---|---|
| Cleft lip with or without cleft palate, US, 2016-2020 | 9.69 per 10,000 live births (95% CI 9.55-9.84); 1 in 1,032; about 3,560 cases a year | NBDPN, Stallings et al., Birth Defects Research 2024 |
| Cleft lip alone, US, 2016-2020 | 3.38 per 10,000 live births (95% CI 3.29-3.46); 1 in 2,963; about 1,240 cases a year | NBDPN, Stallings et al., Birth Defects Research 2024 |
| Cleft palate alone, US | About 1 in 1,563 babies | CDC, Cleft Lip / Cleft Palate (2026) |
| US trend, cleft lip with or without cleft palate | 10.47 (1999-2001), 10.63 (2004-2006), 10.00 (2010-2014), 9.69 (2016-2020) per 10,000 | NBDPN, Mai et al. 2019 and Stallings et al. 2024 |
| Any cleft, UK | 1 in 660 births | CRANE Database, 2025 Summary of Findings |
| Orofacial clefts, global range | Between 1 in 1000-1500 births | WHO, Oral Health Fact Sheet 2025 |
| Cleft lip with or without cleft palate, 54 registries in 30 countries | 9.92 per 10,000 (more than 7.5 million births, 2000-2005) | IPDTOC Working Group, Cleft Palate-Craniofacial Journal 2011 |
| New orofacial cleft cases worldwide, 2021 | 183,302 (95% UI 135,255-241,691), down 24.79% from 1990 | GBD 2021, Wang et al., Frontiers in Medicine 2025 |
Most recent available data: the international registry comparison is IPDTOC 2011, covering births in 2000-2005. The US estimates pool 13 population-based surveillance programs covering 4,141,961 live births, and the CDC rounds the headline figure to 1 in 1,031 on its cleft lip and cleft palate page. The WHO range comes from its oral health fact sheet.
2. Timing of Primary Repair Surgery
Timing is the one variable in this roundup with randomized evidence behind it. In the TOPS trial, 558 infants with isolated cleft palate at 23 centers in Brazil, Denmark, Norway, Sweden and the UK were assigned to surgery at 6 or 12 months, and velopharyngeal insufficiency at age 5 occurred in 8.9% of the 6-month group versus 15.0% of the 12-month group (Gamble et al., NEJM 2023). The early group was also ahead at age 1: 84.3% were producing canonical babbling versus 63.6% (risk ratio 1.32; 95% CI 1.19 to 1.48).
Real-world schedules sit well behind the trial. In a US surgical registry the mean age at palate repair was 655.08 days (about 21.5 months, 655.08 / 30.44), with a standard deviation larger than the mean, which signals a long tail of late operations. That leaves 34.9% of palate repairs (100 minus 65.1) outside advised age periods (Koh et al., Journal of Craniofacial Surgery 2024).
| Metric | Value | Source |
|---|---|---|
| Recommended cleft lip repair, US | Within the first 12 months of life | CDC, citing ACPA Parameters of Care |
| Recommended cleft palate repair, US | Within the first 18 months of life, or earlier if possible | CDC, citing ACPA Parameters of Care |
| Mean age at palate repair, Pediatric NSQIP 2012-2020 (N = 13,735) | 655.08 days (SD 694.43); 65.1% within advised age period | Koh et al., Journal of Craniofacial Surgery 2024 |
| Mean age at cleft lip repair, Pediatric NSQIP 2012-2020 (N = 9,374) | 200.99 days (SD 251.12); 69.0% within advised age period | Koh et al., Journal of Craniofacial Surgery 2024 |
| Mean age at palatoplasty, Kids’ Inpatient Database 1997-2009 (7,218 children) | 12.1 months (95% CI 12.0-12.3) | Harb et al., Cureus 2021 |
| Palate repairs done before 7 months, California 2000-2021 | 12,169 of 52,007 (23.3%) | Stanton et al., Journal of Craniofacial Surgery 2025 |
| UK service targets and delays, 2024 | Most services aim for lip repair by 3 or 4 months and palate repair by 9 months; 33% reported delays | CRANE Database, 2025 Annual Report |
| Velopharyngeal insufficiency at age 5, surgery at 6 vs 12 months | 8.9% (21/235) vs 15.0% (34/226); risk ratio 0.59 (95% CI 0.36 to 0.99; P = 0.04) | TOPS trial, Gamble et al., NEJM 2023 |
Access to timely repair is not evenly distributed inside the US. In the Kids’ Inpatient Database, adjusted mean age at palatoplasty was 15.7 months for Asian children versus 12.1 months for White children (difference 3.60 months, p<0.0001), and 14.3 months in the Midwest versus 12.9 months in the Northeast (Harb et al., Cureus 2021). Most recent available data: that database analysis ends in 2009. Team care runs through accredited centers: ACPA counts approximately 200 approved teams in the US and Canada (ACPA, What Is a Cleft Team).
3. Speech Outcomes at Age 5
The national average hides a steep gradient by cleft type. Standard 1 speech was reached by 69% of children with cleft palate alone but only 24% of those with bilateral cleft lip and palate, a 45-point spread (69 minus 24) inside one health system (CRANE Database, 2025 Annual Report). Girls also did better than boys (58% versus 51%, p=0.008).
Where a child is treated matters too. Standard 1 rates ranged from 33% to 71% across UK cleft services, and the variation survived adjustment for cleft type, extent of hard palate involvement, Robin Sequence status and sex. The 2025 result is 3 points below the 57% reported for children born in 2015-2017. The audit’s speech leads caution that the pandemic disrupted data collection for the 2016 birth cohort, a period covered in our early childhood speech and language delay statistics.
| Metric | Value | Source |
|---|---|---|
| Speech standard 1 (no structural problem, no cleft speech characteristics needing intervention), births 2016-2018 | 54% overall (service range 33%-71%, p<0.001); cleft palate alone 69%, unilateral cleft lip and palate 44%, bilateral cleft lip and palate 24% (p<0.001) | CRANE Database, 2025 Annual Report |
| Speech standard 2a (no evidence of a structurally related speech difficulty, no speech surgery history) | 74% (service range 60%-88%) | CRANE Database, 2025 Annual Report |
| Speech standard 3 (no significant cleft-related speech characteristics that may need therapy or surgery) | 62% (service range 40%-76%), down from 65% for births 2015-2017 | CRANE Database, 2025 Annual Report |
| Intelligibility rated ‘normal’, unilateral cleft lip and palate, after vs before UK centralization | 56.3% (Cleft Care UK) vs 19.6% (CSAG 1998), p < 0.001 | Sell et al., Cleft Care UK Part 4, 2015 |
| Hypernasality, unilateral cleft lip and palate, after vs before centralization | 10.2% (25/245) vs 17.6% (42/238); risk ratio 0.58 | Sell et al., Cleft Care UK Part 4, 2015 |
| Percent consonants correct at age 5, isolated cleft palate | Median 88.9 in both the 6-month and 12-month surgery groups | TOPS trial, Gamble et al., NEJM 2023 |
| Speech intelligibility at age 5, bilateral cleft lip and palate, single center (n = 52) | Completely intelligible 25.0%; mostly intelligible despite some errors 44.2% | Koh et al., Archives of Plastic Surgery 2024 |
Most recent available data: the Cleft Care UK speech study assessed 248 five-year-olds born between April 2005 and March 2007. It remains the reference point because it compared outcomes before and after UK cleft care was centralized into high-volume centers. Just under 20% of children in both the before and after datasets still fell in the two most severe intelligibility categories.
4. Velopharyngeal Insufficiency, Fistula and Secondary Speech Surgery
Secondary surgery rates describe local practice as much as clinical need. UK cleft services ranged from 4% to 32% of children having velopharyngeal surgery or fistula repair for speech before age 5, around a national figure of 14% (CRANE Database, 2025 Annual Report). Among the 188 children who had it, 59% had no structural issues afterwards and 42% continued to have them. A further 14% of the 1,116 children who had no such surgery still showed evidence of a structurally related speech problem.
The TOPS trial shows the same tension. The 6-month group had less velopharyngeal insufficiency at age 5 yet more secondary surgery for it (9.7% versus 5.9%), a pattern the headline outcome alone would not predict. Technique shifts the baseline as well: pooled speech-correcting surgery rates were 19% after straight-line palatoplasty against 6% after Z-palatoplasty (Hofman et al., Clinical Oral Investigations 2023).
| Metric | Value | Source |
|---|---|---|
| Secondary surgery for speech before age 5, UK | 14% (188 children); service range 4%-32%, p<0.001 | CRANE Database, 2025 Annual Report |
| Mean age at surgery for velopharyngeal insufficiency, Pediatric NSQIP 2012-2020 (N = 3,026) | 7.58 years (SD 3.98); 27.7% within advised age period | Koh et al., Journal of Craniofacial Surgery 2024 |
| Speech-correcting surgery needed, cohort of 239 patients with primary palatoplasty in 2008-2017 | 49% | Hofman et al., Cleft Palate-Craniofacial Journal 2026 |
| Secondary surgery for velopharyngeal insufficiency, palate repair at 6 vs 12 months | 9.7% (27 children) vs 5.9% (16 children) | TOPS trial, Gamble et al., NEJM 2023 |
| Fistula after primary repair, surgery at 6 vs 12 months | 15.0% (40/266) vs 12.9% (33/256); risk ratio 1.17 (95% CI 0.76 to 1.79) | TOPS trial, Gamble et al., NEJM 2023 |
| Pooled fistula incidence after primary palate repair (44 studies, 9,294 patients) | 8.6% (95% CI 6.4 to 11.1); 17.9% in cleft lip and palate vs 5.4% in cleft palate alone | Hardwicke et al., Plastic and Reconstructive Surgery 2014 |
| Pooled speech-correcting surgery rate by technique (54 studies) | Straight-line 19% (95% CI 15-24); Z-palatoplasty 6% (95% CI 4-9); buccal flaps 7% (95% CI 4-11) | Hofman et al., Clinical Oral Investigations 2023 |
| Velopharyngeal insufficiency surgery, palate repair before 7 months vs after 11 months, California | 1.2% vs 6.1% | Stanton et al., Journal of Craniofacial Surgery 2025 |
Outliers sit far above the pooled averages. Next to the 49% in the 2026 cohort, a Korean series of 52 children with bilateral cleft lip and palate recorded secondary palatoplasty in 51.9% before age 5 (Koh et al., Archives of Plastic Surgery 2024). Timing is a second gap: in the US registry, fewer than 3 in 10 operations for velopharyngeal insufficiency fell within the advised age period.
Most recent available data: the fistula meta-analysis dates from 2014. Resonance in these audits is judged perceptually by trained listeners; instrument-based measures used elsewhere in voice clinics are covered in our acoustic voice analysis statistics.
5. Hearing, Otitis Media With Effusion and Speech Therapy Need
Middle-ear problems are the norm in infancy and fade slowly. At age 1, 88.1% of infants in the 12-month surgery group had a flat-line tympanogram in at least one ear, against 69.7% of those repaired at 6 months (TOPS trial, NEJM 2023). By age 5 the two groups had converged, with about 4 in 10 children in each showing an abnormal pure-tone result in at least one ear. The early hearing advantage did not persist.
Hearing and speech outcomes travel together. In the Cleft Care UK cohort, a history of otitis media with effusion plus hearing loss was associated with nearly three times the odds of poor speech intelligibility (Hall et al., Cleft Care UK Part 2, 2017). Follow-up is the weak link: in England only 72% of children with a cleft palate (with or without cleft lip) had an audiology assessment recorded, against a suggested benchmark of 100% (CRANE Database, 2024 Annual Report). Among children with a clear newborn screen, temporary conductive hearing loss was later recorded in 17% of those with a cleft palate (with or without cleft lip) versus 2% of those with cleft lip alone.
| Metric | Value | Source |
|---|---|---|
| Flat-line tympanogram in at least one ear at age 1, palate repair at 6 vs 12 months | 69.7% (122/175) vs 88.1% (177/201); risk ratio 0.79 (95% CI 0.71 to 0.88) | TOPS trial, Gamble et al., NEJM 2023 |
| Abnormal sound-field audiometry at age 1, palate repair at 6 vs 12 months | 29.3% (51/174) vs 50.3% (87/173); risk ratio 0.58 (95% CI 0.44 to 0.77) | TOPS trial, Gamble et al., NEJM 2023 |
| Abnormal pure-tone audiometry in at least one ear at age 5 | 40.0% (78/195) vs 38.0% (70/184); risk ratio 1.05 (95% CI 0.82 to 1.35) | TOPS trial, Gamble et al., NEJM 2023 |
| Audiology outcome after newborn screening, children with a cleft, England (births 2006-2021) | Of 7,116 assessed: 47% satisfactory hearing in both ears, 38% hearing loss identified, 4% permanent hearing loss | CRANE Database, 2024 Annual Report |
| Ventilation tube use in children with cleft palate and otitis media with effusion (9 cohort studies) | Tubes inserted in 38% to 53% of cases; complications in about 11% to 37% | Kuo et al., Pediatrics 2014 |
| Poor speech intelligibility at age 5 with a history of otitis media with effusion and hearing loss | Adjusted odds ratio 2.87 (95% CI 1.42-5.77) | Hall et al., Cleft Care UK Part 2, 2017 |
| Poor speech intelligibility at age 5 with a history of speech intervention, unilateral cleft lip and palate | Odds ratio 0.1 (95% CI 0.0 to 0.4) | Sell et al., Cleft Care UK Part 4, 2017 |
| Speech therapy received or referred by age 5, bilateral cleft lip and palate, single center (n = 52) | 76.9%; 48.1% still needed therapy at age 5 | Koh et al., Archives of Plastic Surgery 2024 |
We found no national US figure for speech therapy need, so the UK audit is the closest proxy: 62% of children met speech standard 3, which leaves 38% (100 minus 62) with cleft-related speech characteristics that may require therapy or surgery (CRANE Database, 2025 Annual Report). In Cleft Care UK, children with a history of speech intervention had about one-tenth the odds of poor intelligibility (Sell et al., Cleft Care UK Part 4, 2017). Most recent available data: the ventilation tube review searched the literature to November 2013, and the Cleft Care UK hearing and speech intervention analyses were published in 2017.
The newborn screening pathway that feeds these audiology figures is described in our auditory brainstem response testing statistics.
6. Global Burden, Surgical Backlog and Access
Deaths from clefts have collapsed while the number of people living with one has grown. Global deaths fell 86.09% between 1990 and 2021, yet prevalent cases rose from 2,937,707 to 4,124,007, and 81.0% of prevalent cases and 96.1% of deaths sit in low- and middle-SDI countries (GBD 2021, Wang et al. 2025; Ma et al. 2025). The burden is shifting from survival toward long-term rehabilitation: repair, speech and hearing care.
The backlog estimate is a decade old and the most recent one we could trace. It was built from Operation Smile program data in 12 countries and extrapolated to 113 (Carlson et al., World Journal of Surgery 2016). Charity volume gives a sense of scale against it: Smile Train alone supported 94,461 cleft surgeries in calendar 2025.
| Metric | Value | Source |
|---|---|---|
| People living with an orofacial cleft, 2021 | 4,124,007 (95% UI 3,318,692-5,026,200), up from 2,937,707 in 1990 | GBD 2021, Ma et al., Frontiers in Pediatrics 2025 |
| Disability-adjusted life years, 2021 | 408,775 (95% UI 252,320-671,120), down 68.32% from 1990 | GBD 2021, Wang et al., Frontiers in Medicine 2025 |
| Deaths, 2021 | 1,718.6 (95% UI 484.8-4,409.5), down 86.09% from 1990 | GBD 2021, Wang et al., Frontiers in Medicine 2025 |
| Share of burden in low- and middle-SDI countries | 81.0% of prevalent cases; 96.1% of deaths | GBD 2021, Ma et al., Frontiers in Pediatrics 2025 |
| Age-standardized prevalence, highest vs lowest region | South Asia 89.1 vs High-income North America 19.7 per 100,000 | GBD 2021, Wang et al., Frontiers in Medicine 2025 |
| Unrepaired cleft lip and palate cases, 113 low- and middle-income countries | 616,655 (95% CI 564,893-678,503); median 10.7 per 100,000, from 2.5 (Romania) to 28.5 (Cambodia) | Carlson et al., World Journal of Surgery 2016 |
| Smile Train-supported cleft surgeries | 94,461 in 77 countries in calendar 2025; more than 2,000,000 since 1999 | Smile Train, Spring FY26 Impact Report and FY24 Annual Report |
| People without access to safe, timely, affordable surgery and anesthesia | About 5 billion; 143 million more procedures needed annually | Lancet Commission on Global Surgery 2015, as reported by Harvard Medical School |
Asia accounted for 70,607 of Smile Train’s 2025 surgeries, and the charity also logged 80,214 speech interventions that year, more than its orthodontic (25,903) and nutrition (25,769) services combined (Smile Train, Spring FY26 Impact Report). Most recent available data: the backlog model is from 2016 and the Lancet Commission figures from 2015.
Summary: Cleft Lip and Palate Speech Outcomes by the Numbers
| Metric | Value | Source |
|---|---|---|
| Cleft lip with or without cleft palate, US | 9.69 per 10,000 live births; 1 in 1,032 | NBDPN, Stallings et al., Birth Defects Research 2024 |
| Cleft palate alone, US | About 1 in 1,563 babies | CDC, Cleft Lip / Cleft Palate (2026) |
| New orofacial cleft cases worldwide, 2021 | 183,302 | GBD 2021, Wang et al., Frontiers in Medicine 2025 |
| Recommended palate repair, US | Within the first 18 months of life, or earlier if possible | CDC, citing ACPA Parameters of Care |
| US palate repairs within advised age period | 65.1% (mean age 655.08 days) | Koh et al., Journal of Craniofacial Surgery 2024 |
| Velopharyngeal insufficiency at age 5, repair at 6 vs 12 months | 8.9% vs 15.0%; risk ratio 0.59 | TOPS trial, Gamble et al., NEJM 2023 |
| Velopharyngeal insufficiency surgery, repair before 7 months vs after 11 months, California | 1.2% vs 6.1% | Stanton et al., Journal of Craniofacial Surgery 2025 |
| Speech standard 1 at age 5, UK | 54% overall; 69% cleft palate alone, 44% unilateral and 24% bilateral cleft lip and palate | CRANE Database, 2025 Annual Report |
| Intelligibility rated ‘normal’ after vs before UK centralization | 56.3% vs 19.6% | Sell et al., Cleft Care UK Part 4, 2015 |
| Hypernasality after vs before UK centralization | 10.2% vs 17.6% | Sell et al., Cleft Care UK Part 4, 2015 |
| Secondary surgery for speech before age 5, UK | 14% (service range 4%-32%) | CRANE Database, 2025 Annual Report |
| Pooled speech-correcting surgery, straight-line vs Z-palatoplasty | 19% vs 6% | Hofman et al., Clinical Oral Investigations 2023 |
| Pooled fistula incidence after primary palate repair | 8.6% (95% CI 6.4 to 11.1) | Hardwicke et al., Plastic and Reconstructive Surgery 2014 |
| Flat-line tympanogram in at least one ear at age 1 | 69.7% (6-month repair) vs 88.1% (12-month repair) | TOPS trial, Gamble et al., NEJM 2023 |
| Ventilation tubes in children with cleft palate and otitis media with effusion | Inserted in 38% to 53% of cases | Kuo et al., Pediatrics 2014 |
| Poor speech intelligibility with a history of otitis media with effusion and hearing loss | Adjusted odds ratio 2.87 (95% CI 1.42-5.77) | Hall et al., Cleft Care UK Part 2, 2017 |
| People living with an orofacial cleft, 2021 | 4,124,007 | GBD 2021, Ma et al., Frontiers in Pediatrics 2025 |
| Share of burden in low- and middle-SDI countries | 81.0% of prevalent cases; 96.1% of deaths | GBD 2021, Ma et al., Frontiers in Pediatrics 2025 |
| Unrepaired clefts, 113 low- and middle-income countries | 616,655 | Carlson et al., World Journal of Surgery 2016 |
| Smile Train-supported cleft surgeries, calendar 2025 | 94,461 in 77 countries | Smile Train, Spring FY26 Impact Report |
Methodology and Sources
We ran targeted searches for birth prevalence, repair timing, age-5 speech outcomes, secondary surgery, hearing and global access, then traced each figure to the registry report, trial or peer-reviewed paper that produced it. Figures seen only in search snippets or in secondary blogs were dropped. Where a paper was read through its Europe PMC record, the link below points to the publisher’s DOI.
- National Birth Defects Prevention Network, Stallings et al., National population-based estimates for major birth defects, 2016-2020 (Birth Defects Research 2024): US prevalence, annual cases and time trend.
- NIDCR, Prevalence of Cleft Lip and Cleft Palate: the 2010-2014 estimates from Mai et al., Birth Defects Research 2019.
- CDC, Cleft Lip / Cleft Palate: headline US figures and the ACPA-based surgery timing recommendations.
- CRANE Database, 2025 Annual Report and its summary of findings for the cleft community: UK registry of 25,862 children, speech standards for births in 2016-2018, organisational audit.
- CRANE Database, 2024 Annual Report: linkage of 11,574 children to newborn hearing screening records in England.
- Gamble et al., Timing of Primary Surgery for Cleft Palate (TOPS), New England Journal of Medicine 2023: randomized evidence on speech, hearing and complications.
- Sell et al., The Cleft Care UK study, Part 4: perceptual speech outcomes (Orthodontics and Craniofacial Research 2015) and Hall et al., Cleft Care UK Part 2 (2017): before and after comparison with the 1998 CSAG audit, hearing and speech links. The speech intervention odds ratio is from Sell et al., Cleft Care UK Part 4 (2017), read through its Europe PMC record.
- Koh et al., The Life Cycle of Orofacial Cleft Operations (Journal of Craniofacial Surgery 2024): Pediatric NSQIP 2012-2020 ages at surgery.
- Harb et al., Race, Income, and the Timeliness of Cleft Palate Repair in the United States (Cureus 2021): Kids’ Inpatient Database 1997-2009.
- Stanton et al., Early Cleft Palate Repair is Associated With Lower Incidence of Velopharyngeal Insufficiency Surgery (Journal of Craniofacial Surgery 2025): California statewide cohort.
- Hofman et al., Speech correcting surgery after primary palatoplasty (Clinical Oral Investigations 2023) and Hofman et al., Cleft Palate-Craniofacial Journal 2026: pooled and cohort-level secondary surgery rates.
- Hardwicke et al., Fistula incidence after primary cleft palate repair (Plastic and Reconstructive Surgery 2014): pooled fistula incidence.
- Kuo et al., Grommets for otitis media with effusion in children with cleft palate (Pediatrics 2014): ventilation tube use and complications.
- Koh et al., Speech Outcomes in 5-Year-Old Korean Children with Bilateral Cleft Lip and Palate (Archives of Plastic Surgery 2024): single-center therapy and secondary surgery rates.
- Wang et al., Global, regional, and national burden of orofacial clefts, 1990-2021 (Frontiers in Medicine 2025) and Ma et al., Burden of orofacial clefts from 1990-2021 (Frontiers in Pediatrics 2025): secondary analyses of GBD 2021.
- WHO, Oral Health Fact Sheet (17 March 2025) and IPDTOC Working Group, Cleft Palate-Craniofacial Journal 2011: global prevalence range and international registry data.
- Carlson et al., A Model of the Unmet Need for Cleft Lip and Palate Surgery in Low- and Middle-Income Countries (World Journal of Surgery 2016): backlog model.
- Smile Train, Spring FY26 Impact Report and Smile Train, FY24 Annual Report: surgery and speech service volumes.
- Harvard Medical School, Mapping the Future of Global Surgery (2015): the intermediary through which we read the Lancet Commission on Global Surgery figures.
- ACPA, What Is a Cleft Team: number of approved teams.
- Data watch: (1) US and UK prevalence figures use different case definitions, and the combined US figure in section 1 is our own arithmetic. The CDC rounds the cleft lip figure to 1 in 1,031 while the underlying paper prints 1 in 1,032, and the cleft palate alone figure is quoted from the CDC page only. (2) CRANE speech results cover 70% of eligible children, up from 54% a year earlier, and include a 2016 birth cohort whose assessments were disrupted by the pandemic; the report’s own speech leads advise caution when comparing services. The report’s key findings table prints 15% for secondary speech surgery while the corrected speech chapter (version 1.2, February 2026) prints 14%, which we use, and its 59% and 42% post-surgery shares sum to 101% as published. (3) The TOPS primary result (P = 0.04) weakened in a multiple-imputation sensitivity analysis (risk ratio 0.62; 95% CI 0.37 to 1.03; P = 0.07), and the trial did not record ventilation tube placement. (4) Stanton et al. print the early-repair rate as 1.2% alongside 13 per 1,000. (5) The two GBD 2021 secondary analyses agree on counts, but the abstract of Ma et al. describes the change in prevalent cases as a decrease while its own counts show a rise and Wang et al. report an increase of 40.3%. (6) Global prevalence statements conflict: WHO gives 1 in 1000-1500 births, Smile Train uses about 1 in 700, and the IPDTOC registries measured 9.92 per 10,000 for cleft lip with or without cleft palate only. (7) Pooled fistula, ventilation tube, backlog and global surgery figures are more than three years old and are flagged in each section. Operation Smile’s 2025 Year in Review was checked but its web page carried no program totals, so no figure is cited from it.
Last updated: October 11, 2026. We update this roundup quarterly, and the next refresh is expected when the CRANE Database 2026 Annual Report is published (the 2025 edition was released on 8 December 2025).