Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate
NCT07927933, Not applicable, Recruiting, Phoenix Children's Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate | ClinicalTrials.gov |
| NCT number | NCT07927933 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 74 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Phoenix Children's Hospital | ClinicalTrials.gov |
| Conditions | Cleft Palate, Cleft Palate +/- Lip, Orofacial Cleft | ClinicalTrials.gov |
| Interventions | Unidirectional feeding valve | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Milk volume intake | Immediately after the observed feeding session | 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. | ClinicalTrials.gov |
| Secondary | Caregiver-Reported Feeding Quality Using the Infants with Orofacial Cleft: Observable Outcomes (iCOO) Feeding Domain | Immediately following the observed feeding session | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)