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Use of Prokinetics in Early Enteral Feeding in Preterm Infants

NCT01569633 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

  • Feeding Disorder
  • Nutrition Disorder
  • Infant,Premature

Interventions

DRUG

Metclopramide

Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.

DRUG

Erythromycin

Dose of erythromycin is 1 miligram per kilogram every eight hours

DRUG

placebo

The dose of sugar water is 1 ml per 8 hours.

Sponsors & Collaborators

  • East Tennessee State University

    lead OTHER

Principal Investigators

  • Darshan S Shah, MD · East Tennessee State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-28
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569633 on ClinicalTrials.gov