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WithdrawnNCT01569633Updated Nov 21, 2022

Use of Prokinetics in Early Enteral Feeding in Preterm Infants

An interventional study of Metclopramide and Erythromycin in Feeding Disorder, Nutrition Disorder and Infant,Premature, sponsored by East Tennessee State University. Withdrawn at 1 site in United States. Open to participants aged Up to 14 Days. Per ClinicalTrials.gov, last updated 2022-11-21.

Sponsored by East Tennessee State University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
very poor enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
Up to 14 Days
Sex
All
01

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.
Read the 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.
02

Conditions studied

  • Feeding Disorder
  • Nutrition Disorder
  • Infant,Premature
03

In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

Browse Nutrition Disorders studies →

Lead sponsor

East Tennessee State University is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    This group of infant will not receive any medication but sugar water or placebo

    Drug: placebo

  • Active comparator
    Metclopramide

    This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.

    Drug: Metclopramide

  • Active comparator
    Erythromycin

    mediaction used to treat feeding disorder

    Drug: Erythromycin

Interventions

  • DrugMetclopramide

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

    Also known as: reglan

  • DrugErythromycin

    Dose of erythromycin is 1 miligram per kilogram every eight hours

  • Drugplacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 MONTHS

Secondary outcomes

  1. 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,

    Time frame: 24 months

07

Study locations

1 site
  • East Tennessee State University
    Johnson City, Tennessee 37604, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01569633
Lead sponsor
East Tennessee State University
Responsible party
Darshan Shah, M.D. (Asst. Professor of Pediatrics, East Tennessee State University) — Principal investigator
First posted
Apr 3, 2012
Start date
Oct 2011
Primary completion
Feb 2014
Completion
Dec 2015
Last update
Nov 21, 2022

Study contacts

Darshan S Shah, MD
principal investigator · East Tennessee State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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