Surgery for Isolate Cleft Palate at 6 Months Yields Better Outcomes Than at 12 Months

WEDNESDAY, Aug. 30, 2023 (HealthDay News) — Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at 5 years of age versus those who had surgery at 12 months of age, according to a study published in the Aug. 31 issue of the New England Journal of Medicine.

Carrol Gamble, Ph.D., from University of Liverpool in the United Kingdom, and colleagues randomly assigned (1:1) infants with nonsyndromic isolated cleft palate to undergo standardized primary surgery at 6 months of age or at 12 months of age for closure of the cleft. The analysis included 558 infants treated at 23 centers across Europe and South America.

The researchers found insufficient velopharyngeal function at 5 years of age in 21 of 235 infants (8.9 percent) in the 6-month group versus 34 of 226 (15.0 percent) in the 12-month group (risk ratio, 0.59; P = 0.04). Postoperative complications were infrequent and similar between the groups. Three serious adverse events were reported in the 6-month group versus one in the 12-month group.

“Additional benefits of early surgery include canonical babbling, hearing sensitivity, and middle-ear function at 1 year of age,” the authors write. Risks associated with earlier repair may include maxillary arch constriction and the need for secondary surgery for velopharyngeal insufficiency.”

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