An interventional study of Unidirectional feeding valve in Cleft Palate, Cleft Palate +/- Lip and Orofacial Cleft, sponsored by Phoenix Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Phoenix Children's Hospital · Not applicable, Interventional, and Treatment
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.
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:
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.
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 74 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Unidirectional feeding valve
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.
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
Milk volume intake
Total milk volume consumed (mL) during a single observed feeding session will be measured and compared between infants with unrepaired cleft palate randomized to feed using bottles with versus without a unidirectional valve.
Time frame: Immediately after the observed feeding session
Caregiver-Reported Feeding Quality Using the Infants with Orofacial Cleft: Observable Outcomes (iCOO) Feeding Domain
Caregiver-reported feeding quality will be assessed using the feeding domain of the Infants with Orofacial Cleft: Observable Outcomes (iCOO) questionnaire. The instrument includes 10 items assessing feeding behaviors and difficulties using a three-point ordinal response scale (none of the time, some of the time, all of the time) and one item assessing overall feeding ability using a five-point ordinal response scale (excellent, very good, good, fair, poor). Caregiver responses will be compared between infants with unrepaired cleft palate randomized to feed using bottles with versus without a unidirectional valve.
Time frame: Immediately following the observed feeding session
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2028, 26 months after the start.
Of 34 non-industry interventional studies with no phase under Cleft Palate, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 26 months is above that.
Counting every sponsor, half of 34 studies reached it within 18 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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