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Use of Prokinetics in Early Enteral Feeding in Preterm Infants

Primary Purpose

Feeding Disorder, Nutrition Disorder, Infant,Premature

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metclopramide
Erythromycin
placebo
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Disorder

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Metclopramide

Erythromycin

Arm Description

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

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

mediaction used to treat feeding disorder

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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,

Full Information

First Posted
March 30, 2012
Last Updated
November 17, 2022
Sponsor
East Tennessee State University
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1. Study Identification

Unique Protocol Identification Number
NCT01569633
Brief Title
Use of Prokinetics in Early Enteral Feeding in Preterm Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
very poor enrollment
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Weight below 1250 grams Age less than 14 days 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 GI malformation or perforation Genetic disorder 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Disorder, Nutrition Disorder, Infant,Premature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group of infant will not receive any medication but sugar water or placebo
Arm Title
Metclopramide
Arm Type
Active Comparator
Arm Description
This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.
Arm Title
Erythromycin
Arm Type
Active Comparator
Arm Description
mediaction used to treat feeding disorder
Intervention Type
Drug
Intervention Name(s)
Metclopramide
Other Intervention Name(s)
reglan
Intervention Description
Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Description
Dose of erythromycin is 1 miligram per kilogram every eight hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The dose of sugar water is 1 ml per 8 hours.
Primary Outcome Measure Information:
Title
Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL
Description
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 Outcome Measure Information:
Title
Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial.
Description
Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,
Time Frame
24 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight below 1250 grams Age less than 14 days 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 GI malformation or perforation Genetic disorder 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darshan S Shah, MD
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Prokinetics in Early Enteral Feeding in Preterm Infants

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