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

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.

Study Overview

• Status: Withdrawn
• Conditions: Feeding Disorder; Infant,Premature; Nutrition Disorder
• Intervention / Treatment: Drug: placebo; Drug: Metclopramide; Drug: Erythromycin

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; This group of infant will not receive any medication but sugar water or placebo	Drug: placebo; The dose of sugar water is 1 ml per 8 hours.
Active Comparator: Metclopramide; This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.	Drug: Metclopramide; Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.; Other Names: reglan
Active Comparator: Erythromycin; mediaction used to treat feeding disorder	Drug: Erythromycin; Dose of erythromycin is 1 miligram per kilogram every eight hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: East Tennessee State University
• Investigators: Principal Investigator: Darshan S Shah, MD, East Tennessee State University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 30, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Feeding and Eating Disorders; Nutrition Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
• Other Study ID Numbers: ft2011ep