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Method of Studying Palatal Fusion using Static Organ Culture
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Timing of Primary Surgery for Cleft Palate.

Carrol Gamble1, Christina Persson1, Elisabeth Willadsen1

  • 1From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and Leeds General Infirmary (C.L.), Leeds, Cleft Care Scotland, Glasgow (L.C.), Bristol Dental Hospital, Bristol (L.A.), the University of Manchester (J.C.-S., A.E.-A., G.S., K.M., T.W., W.S.) and Manchester University NHS Foundation Trust (M.B., K.P.), Manchester, Birmingham Children's Hospital (B.F.) and Birmingham Women's and Children's NHS Foundation Trust (I.U.), Birmingham, Salisbury District Hospital, Salisbury (G.P.), Royal Victoria Infirmary, Newcastle upon Tyne (L.R., S.E.), and Oxford University Hospitals NHS Foundation Trust, Oxford (L.S.) - all in the United Kingdom; the University of Gothenburg (C.P.) and Sahlgrenska University Hospital (C.H.), Gothenburg, Uppsala University Hospital, Uppsala (M.A., E.L.), Linköping University Hospital, Linköping (P.B., A.-S.B.T.), Umeå University (K.B.) and Norrlands University Hospital (J.E.W.), Umeå, Skåne University Hospital, Malmö (K.K., M.S.), Karolinska Institutet, Solna (A.L., J.N.), and Karolinska University Hospital, Stockholm (L.R.W.) - all in Sweden; the University of Copenhagen (E.W., L.D.J.) and Copenhagen Cleft Palate Center (H.S.A., L.D.J.), Copenhagen, and the Cleft Palate Center, Aarhus (B.K.E., L.L., J.B.N.) - all in Denmark; the University of São Paulo, Bauru, Brazil (M.Z.A., A.P.F., C.G.A.B.G., H.C.M., S.H.A.P.-P., I.E.K.T., R.P.Y.); and Statped (R.A., A.K.H., M.B.K., J.L.) and Statped Sørøst (M.M.), Oslo, and Statped Vest, Bergen (N.-H.P., J.T.) - all in Norway.

The New England Journal of Medicine
|August 30, 2023
PubMed
Summary

Early cleft palate surgery at 6 months significantly reduces velopharyngeal insufficiency by age 5 compared to 12 months. This benefits speech outcomes in infants with isolated cleft palate.

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Area of Science:

  • Craniofacial Surgery
  • Pediatric Otolaryngology
  • Speech-Language Pathology

Background:

  • The optimal timing for primary surgery in infants with isolated cleft palate remains unclear regarding long-term outcomes.
  • Key areas of investigation include speech, hearing, dentofacial development, and patient safety.

Purpose of the Study:

  • To compare the efficacy of primary cleft palate surgery at 6 months versus 12 months of age.
  • To evaluate the impact of surgical timing on velopharyngeal function, speech development, hearing, and dentofacial outcomes.

Main Methods:

  • A randomized controlled trial assigned 558 infants with nonsyndromic isolated cleft palate to surgery at 6 or 12 months.
  • Speech and language therapists assessed velopharyngeal function via standardized recordings at 5 years of age.
  • Primary outcome: velopharyngeal insufficiency (VPI) score ≥4 at age 5; secondary outcomes included speech, hearing, dentofacial development, and complications.

Main Results:

  • Fewer infants in the 6-month group (8.9%) experienced VPI at age 5 compared to the 12-month group (15.0%), a statistically significant difference (RR 0.59, P=0.04).
  • Postoperative complications and serious adverse events were infrequent and comparable between the two groups.
  • Speech recordings were analyzed from 83.6% of the 6-month group and 81.6% of the 12-month group.

Conclusions:

  • Primary cleft palate surgery at 6 months of age leads to a lower incidence of velopharyngeal insufficiency at 5 years compared to surgery at 12 months.
  • This earlier surgical timing appears beneficial for speech outcomes in infants with isolated cleft palate.
  • The study was conducted in well-resourced settings and funded by the National Institute of Dental and Craniofacial Research.