Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate

Cleft lip and/or palate is one of the most common birth differences worldwide, affecting between 6,000-8,000 children annually in the United States alone. Infants with cleft palate commonly experience immediate feeding difficulty because of an inability to generate sufficient negative intraoral pressure for suction. Feeding inefficiency can contribute to poor weight gain, which can delay surgical palate repair and negatively affect later speech outcomes. Cleft-adapted bottles with unidirectional valves have become a frequent recommendation across North America to address feeding difficulties. Although cleft-adapted bottles with unidirectional valves are often the first recommendation made by cleft teams for infants with cleft palate, this recommendation is based on clinical expertise rather than scientific evidence.

The most recent Cochrane review evaluating the evidence for feeding interventions for infants with cleft palate was completed in 2011. The review indicated that squeeze-assisted bottles-where the caregiver squeezes the nipple or bottle base to deliver milk into the infant's mouth-were easier to use for infants with cleft palate than standard rigid bottles. Squeeze-assisted bottles are now rarely used in clinical care, as newer bottles have emerged with unidirectional valves that allow infants to play an active role in directing feeding. Updated systematic reviews from 2016 and 2023 have continued to include the same limited set of studies, primarily comparing rigid and squeezable bottles. Importantly, no studies have examined differences in milk volume intake between cleft-adapted bottles with and without unidirectional valves. Reviews spanning a 12-year period indicate that limited original research has been undertaken in this area despite the emergence and widespread use of new bottle systems.

The disconnect between available scientific evidence and current clinical practice reveals a gap in evidence-based care. Interdisciplinary healthcare providers-including primary care physicians, nurses, physician assistants, and speech-language pathologists-play a critical role in helping infants with cleft palate establish successful feeding. Consequently, evidence is needed to determine whether cleft-adapted bottles with unidirectional valves improve oral intake in infants with cleft palate. The proposed project will address this gap through two specific aims:

1. To compare milk volume intake, milk transfer rate, and feeding proficiency during an observed feeding in infants with unrepaired cleft palate using bottles with and without unidirectional valves.
2. To determine the impact of unidirectional valve use on caregiver-rated feeding quality following an observed feeding in infants with unrepaired cleft palate.

The proposed project will use a randomized design, feasible for implementation at a large metropolitan cleft center with an established clinical feeding pathway and sufficient patient volume. The study will generate preliminary comparative data to support future large-scale funding focused on feeding efficacy. Results will contribute to the development of patient-specific, evidence-based treatment pathways focused on nutrition and growth in infants with cleft palate.