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Use of Prokinetics in Early Enteral Feeding in Preterm Infants

This study is currently recruiting participants.
Verified March 2012 by East Tennessee State University
Sponsor:
Information provided by (Responsible Party):
Darshan Shah, M.D., East Tennessee State University
ClinicalTrials.gov Identifier:
NCT01569633
First received: March 30, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Feeding Disorder
Nutrition Disorder
Infant,Premature
 Drug: Metclopramide
Drug: Erythromycin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by East Tennessee State University:

Primary Outcome Measures:
  • Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: reglan
Active Comparator: Erythromycin
mediaction used to treat feeding disorder
 Drug: Erythromycin
Dose of erythromycin is 1 miligram per kilogram every eight hours

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.
  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569633

Contacts
Contact: Darshan d Shah, MD 423-439-6222 shahd@etsu.edu

Locations
United States, Tennessee
East Tennessee State University Recruiting
Johnson City, Tennessee, United States, 37604
Contact: Shah         shahd@etsu.edu    
Sponsors and Collaborators
East Tennessee State University
Investigators
Principal Investigator: Darshan S Shah, MD East Tennessee State University
  More Information

No publications provided

Responsible Party: Darshan Shah, M.D., Asst. Professor of Pediatrics, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01569633     History of Changes
Other Study ID Numbers: ft2011ep
Study First Received: March 30, 2012
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nutrition Disorders
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Metoclopramide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013