Effect of a cleft-adapted bottle with a unidirectional valve on milk intake in infants with cleft palate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares a cleft-adapted bottle featuring a unidirectional valve to a non-cleft-adapted bottle in infants with unrepaired cleft palate under 12 months old. The goal is to measure oral milk volume intake and milk transfer rate during feeding when using expressed breast milk or standard formulas. Eligible participants are cared for at Phoenix Children’s Hospital and must be using a Dr. Brown’s Zero-Resistance or Pigeon Baby Cleft Palate Bottle and feed at IDDSI level 0. The trial addresses a gap in evidence for feeding devices in cleft-related feeding difficulties, where traditional recommendations are largely based on expert opinion rather than randomized data. Results could inform whether valve-equipped bottles improve feeding efficiency and weight gain potential in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Jessica L Chee-Williams, MS — Phoenix Children's Hospital
• Study coordinator: Jessica L Chee-Williams, MS
• Email: jcheewilliams@phoenixchildrens.com
• Phone: 602-933-1050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using neural networks to analyze cleft palate shapes

  This study is testing a new computer program that uses pictures to create 3D models of cleft palates in infants to make treatment planning easier and better for patients.

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• Palatoplasty techniques using PRF and antibiotic-loaded PRF in cleft palate

  This trial tests whether adding autologous PRF or gentamicin-loaded PRF to primary palatoplasty helps kids with unilateral or bilateral cleft palate heal better and have fewer fistulas than standard surgery.

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• Opioid-free versus opioid-based anesthesia for children having cleft lip or palate repair

  This will test whether opioid-free anesthesia can control pain and reduce emergence agitation in children undergoing cleft lip or palate repairs.

  Recruiting University of Zagreb · Zagreb · NCT07557576

• Comparing pain relief methods after cleft palate surgery in children

  This study is testing whether short-acting or long-acting pain medications work better for managing pain in young children after cleft palate surgery.

  Recruiting Phase 4 Duke University · Durham, North Carolina · NCT06962306

• Furlow palatoplasty with buccal flap for speech in children with cleft palate

  This project compares two palate repair methods to see if Furlow palatoplasty with a buccal myomucosal flap leads to better speech than two-flap palatoplasty in children aged 3–5 with nonsyndromic cleft palate.

  Recruiting Fayoum University · Al Fayyum · NCT06856330

• Comparing two pain management techniques for children undergoing palate surgery

  This study is testing two different pain management techniques for kids aged 6-18 who are having palate surgery to see which one helps them feel less pain after the operation.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT06420336

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.