Not a traditional drug phase: Unidirectional feeding valve for Cleft Palate
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.
Official registry: https://clinicaltrials.gov/study/NCT07927933 · Phoenix Children's Hospital · enrollment listed as 74
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Unidirectional feeding valve. The registry lists allocation as randomized. 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.
They plan to enroll about 74 people at Phoenix. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate- A Randomized Controlled Trial
Interventions: Unidirectional feeding valve
Primary outcome (registry wording): Milk volume intake
Who it is for (from inclusion criteria)
- Ages 0 Months to 12 Months
- 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)
Who the registry excludes
- 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
Public study contact (from the registry)
Jessica L Chee-Williams, MS
jcheewilliams@phoenixchildrens.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Phoenix Children's Hospital — Phoenix, Arizona (recruiting)
FAQ about this NCT record
Is NCT07927933 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07927933?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07927933?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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