Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Not Applicable

Withdrawn

• Conditions: Feeding Disorder; Nutrition Disorder; Infant,Premature
• Interventions: Drug: Metclopramide; Drug: placebo; Drug: Erythromycin

• Registration Number: NCT01569633
• Lead Sponsor: East Tennessee State University

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.

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Primary Completion: 2014-02
• Study Completion: 2015-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metclopramide	Metclopramide	This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.
Placebo	placebo	This group of infant will not receive any medication but sugar water or placebo
Erythromycin	Erythromycin	mediaction used to treat feeding disorder

Primary Outcome Measures

Name	Time	Method
Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL	24 MONTHS	Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.

Secondary Outcome Measures

Name	Time	Method
Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial.	24 months	Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,

Trial Locations

Locations (1)

East Tennessee State University; 🇺🇸 Johnson City, Tennessee, United States