Recruiting

Cleft-adapted Bottle

Sponsor:

Phoenix Children's Hospital

Code:

NCT07927933

Conditions

Cleft Palate

Cleft Palate +/- Lip

Orofacial Cleft

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Unidirectional feeding valve

Study Details

Brief summary:

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.

Conditions

Cleft Palate

Cleft Palate +/- Lip

Orofacial Cleft

Study ID

NCT07927933

Start date

Oct 8, 2026

Status verified date

Nov, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Unidirectional Valve group

Infants randomized to the experimental group will complete an observed bottle-feeding session using a cleft-adapted bottle system with a unidirectional valve. The valve is designed to support milk transfer by allowing milk to flow toward the nipple while limiting backflow into the bottle. Milk volume intake, milk transfer rate, and feeding proficiency will be measured during the observed feeding session. Caregivers will also rate their infant's feeding quality following the session.

no intervention: No Unidirectional Valve Group

Infants randomized to the comparator group will complete an observed bottle-feeding session using a bottle system without a unidirectional valve. Infants will rely on their own sucking ability and compression of the nipple to transfer milk. Milk volume intake, milk transfer rate, and feeding proficiency will be measured during the observed feeding session. Caregivers will also rate their infant's feeding quality following the session.

Interventions

Unidirectional feeding valve

Two common cleft-adapted bottle that feature unidirectional valves are the Dr. Brown's® Zero-Resistance Specialty Feeding System® (Dr. Brown's® SFS) and the Pigeon Baby Cleft Palate Bottle. The Dr. Brown's® SFS is currently the most used and recommended cleft-adapted bottle in North America. These bottles feature a unidirectional "check valve" that is inserted into the nipple of the bottle. This unidirectional valve allows milk to flow into the nipple but not back into the bottle, creating a compression nipple that extracts milk when the infant compresses the nipple with their lips, gums, or tongue

Primary outcome measure

  • Milk volume intake [ Time Frame: Immediately after the observed feeding session ]

Central Contacts and Locations

Central contacts

Jessica L Chee-Williams, MS

602-933-1050jcheewilliams@phoenixchildrens.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Jessica L Chee-Williams, MS

602-933-1050jcheewilliams@phoenixchildrens.com

Principal Investigator:

Jessica L Chee-Williams, MS

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Unidirectional valve
  • Feeding
  • Milk transfer rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.