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Use of Prokinetics in Early Enteral Feeding in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01569633
Recruitment Status : Terminated (very poor enrollment)
First Posted : April 3, 2012
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Feeding Disorder Nutrition Disorder Infant,Premature Drug: Metclopramide Drug: Erythromycin Drug: placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, 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
Study Start Date : October 2011
Primary Completion Date : February 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: reglan
Active Comparator: Erythromycin
mediaction used to treat feeding disorder
Drug: Erythromycin
Dose of erythromycin is 1 miligram per kilogram every eight hours


Outcome Measures

Primary Outcome Measures :
  1. Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL [ Time Frame: 24 MONTHS ]
    Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.


Secondary Outcome Measures :
  1. Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. [ Time Frame: 24 months ]
    Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569633


Locations
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37604
Sponsors and Collaborators
East Tennessee State University
Investigators
Principal Investigator: Darshan S Shah, MD East Tennessee State University
More Information

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
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Disease
Nutrition Disorders
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
Metoclopramide
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors