N/A
Completed N=76
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Source: ClinicalTrials.gov NCT02486263 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: CLINICAL OUTCOME OF FEEDING SUCCESS — 33; 44 percentage of participants — p=0.28
Summary
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.
In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CLINICAL OUTCOME OF FEEDING SUCCESS |
33; 44 | 0.28 |
| PRIMARY MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes |
0.5; 0.7 | 0.99 |
| SECONDARY CLINICAL OUTCOMES: Growth Outcome Measure |
27.6; 26.5 | 0.64 |
| SECONDARY CLINICAL OUTCOME: Development Outcome Measures |
17; 20; 4; 0; 1; 2 | 0.11 |
| SECONDARY CLINICAL OUTCOME: Respiratory Outcome Measures |
7; 9 | 0.49 |
Eligibility Criteria
Inclusion Criteria
- Hospitalized infants with aerodigestive or GERD symptoms
- Gestational age ≤42 weeks
- Premature infants are eligible at 34 weeks postmenstrual age (PMA)
- Enteral or Oral Fed
- Average daily total feeding volume ≥ 150ml/kg/day
- Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula
Exclusion Criteria
- Known genetic, metabolic or syndromic disease
- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
- Gastrointestinal malformations and surgical gastrointestinal conditions
Data sourced from ClinicalTrials.gov (NCT02486263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.