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NCT01569633 Clinical Trial

Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Infant,Premature Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01569633
Other study ID # ft2011ep
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date December 2015

Study information
Verified date November 2022
Source East Tennessee State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 14 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metclopramide
Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
• Erythromycin
Dose of erythromycin is 1 miligram per kilogram every eight hours
• placebo
The dose of sugar water is 1 ml per 8 hours.

Locations
Country Name City State
United States East Tennessee State University Johnson City Tennessee

Sponsors (1)
Lead Sponsor Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia, 24 months
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