Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Information source: East Tennessee State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Feeding Disorder; Nutrition Disorder; Infant,Premature
Intervention: Metclopramide (Drug); Erythromycin (Drug); placebo (Drug)
Phase: N/A
Status: Terminated
Sponsored by: East Tennessee State University Official(s) and/or principal investigator(s):
Darshan S Shah, MD, Principal Investigator, Affiliation: East Tennessee State University
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.
Clinical Details
Official title: Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL
Secondary outcome: Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial.
Detailed description:
Inclusion Critera:
1. Weight below 1250 grams
2. Age less than 14 days
3. 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.
Exclusion Criteria
1. GI malformation or perforation
2. Genetic disorder
3. Parents can't read English. After consent, if infants meet inclusion criteria, he would
be allowed to receive one of the following three medication. 1) Erythromycin at
1mg/kg/dose q8 hr 2) Metoclopramide 0. 1mg/kg/dose q8 hrs and Placebo. If infant fails
to get better, he would be crossover to one of the remaining two.
Eligibility
Minimum age: N/A.
Maximum age: 14 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Weight below 1250 grams
2. Age less than 14 days
3. 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.
Exclusion Criteria
1. GI malformation or perforation
2. Genetic disorder
3. Parents can't read English. After consent, if infants meet inclusion criteria, he
would be allowed to receive one of the following three medication. 1) Erythromycin at
1mg/kg/dose q8 hr 2) Metoclopramide 0. 1mg/kg/dose q8 hrs and Placebo. If infant fails
to get better, he would be crossover to one of the remaining two.
Locations and Contacts
East Tennessee State University, Johnson City, Tennessee 37604, United States
Additional Information
Starting date: October 2011
Last updated: February 13, 2015
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