Study Stopped
very poor enrollment
Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Objective of this study are: 1\) To determine if medication help extreme preterm infants to tolerate feeding better by reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1) Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study after parental consent. Infant would be blinded to care givers. Infants will be randomized to receive one of three medication for 7-14 days. If infants fail on one medication they will be allowed to crossover to other medication. Infant would be allowed to treat like other infants. Blindness can be broken if deem necessary by attending neonatologist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 21, 2022
November 1, 2022
2.3 years
March 30, 2012
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL
Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.
24 MONTHS
Secondary Outcomes (1)
Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial.
24 months
Study Arms (3)
Placebo
PLACEBO COMPARATORThis group of infant will not receive any medication but sugar water or placebo
Metclopramide
ACTIVE COMPARATORThis group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.
Erythromycin
ACTIVE COMPARATORmediaction used to treat feeding disorder
Interventions
Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
Eligibility Criteria
You may qualify if:
- Weight below 1250 grams
- Age less than 14 days
- Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.
You may not qualify if:
- GI malformation or perforation
- Genetic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Tennessee State University
Johnson City, Tennessee, 37604, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darshan S Shah, MD
East Tennessee State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Professor of Pediatrics
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
October 1, 2011
Primary Completion
February 1, 2014
Study Completion
December 1, 2015
Last Updated
November 21, 2022
Record last verified: 2022-11