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The New England Journal of MedicineTiming of Primary Surgery for Cleft Palate

What is the optimal age for cleft palate surgery?

In a recent study, researchers have delved into the optimal timing for primary surgery in infants with nonsyndromic isolated cleft palate, comparing outcomes at 6 months and 12 months of age. The study sheds light on various aspects such as speech outcomes, hearing sensitivity, and safety.

HCN Medical Memo
For physicians treating infants with isolated cleft palates, this study provides compelling evidence that primary surgery at 6 months of age yields better speech outcomes by age 5 compared to surgery at 12 months. This information could be pivotal in your surgical planning and parental counseling.

Study Design:
  • Randomized controlled trial involving 558 infants with nonsyndromic isolated cleft palate.
  • Infants were assigned in a 1:1 ratio to undergo surgery at either 6 months (281 infants) or 12 months (277 infants) of age.
  • Standardized assessments were conducted at 1, 3, and 5 years of age by speech and language therapists who were blinded to the trial-group assignments.
  • Primary outcome was velopharyngeal insufficiency at 5 years of age, with secondary outcomes including speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth.
Key Findings:
  • Insufficient velopharyngeal function at 5 years was observed in 8.9% of infants in the 6-month group compared to 15.0% in the 12-month group (risk ratio, 0.59; 95% CI, 0.36 to 0.99; P=0.04).
  • Postoperative complications were infrequent and similar in both groups.
  • Four serious adverse events were reported, three in the 6-month group and one in the 12-month group, all of which had resolved at follow-up.

Infants who underwent cleft palate surgery at 6 months had a lower risk of velopharyngeal insufficiency at age 5 compared to those who had the surgery at 12 months.

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