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

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

Who can join

0 Months – 12 Months · All sexes

Inclusion Criteria:

* Infants with a diagnosed, unrepaired, overt cleft palate under 12 months gestational age cared for at Phoenix Children's, upon receipt of parental/guardian informed consent to participate.
* Infant is using the Dr. Brown's® Zero-Resistance Specialty Feeding System® (Narrow nipple or wide-neck options) or the Pigeon Baby Cleft Palate Bottle
* Infants feeding using milk at IDDSI level 0 (expressed breast milk, commercial formulas, and formula fortified up to 26kcal/ounce)

Exclusion Criteria:

* Infants with a submucous cleft palate.
* Infants receiving supplemental enteral (e.g. "tube") feedings.
* Infants receiving thickened feeds with infant cereal (oatmeal or rice), Gelmix, or pureed food

About the study

This study aims to assess the impact of using a cleft-adapted bottle with a unidirectional valve compared with a non-cleft-adapted bottle on oral volume intake and milk transfer rate.

What is being tested

• Unidirectional feeding valve (device)

Sponsor: Phoenix Children's Hospital · Participants: 74 · Started: Oct 8, 2026

Contact the study team

• Jessica L Chee-Williams, MS · Phone: 602-933-1050

Official record on ClinicalTrials.gov — NCT07927933

Locations in the U.S.

Conditions

• Cleft Lip and Palate

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.