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Use of Prokinetics in Early Enteral Feeding in Preterm Infants

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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):
Darshan Shah, M.D., East Tennessee State University

March 30, 2012
April 3, 2012
February 16, 2015
October 2011
February 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01569633 on ClinicalTrials.gov Archive Site
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,
Same as current
Not Provided
Not Provided
 
Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo

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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
  • Feeding Disorder
  • Nutrition Disorder
  • Infant,Premature
  • Drug: Metclopramide
    Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
    Other Name: reglan
  • 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.
  • Placebo Comparator: Placebo
    This group of infant will not receive any medication but sugar water or placebo
    Intervention: Drug: placebo
  • Active Comparator: Metclopramide
    This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.
    Intervention: Drug: Metclopramide
  • Active Comparator: Erythromycin
    mediaction used to treat feeding disorder
    Intervention: Drug: Erythromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
90
December 2015
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 14 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01569633
ft2011ep
Yes
Not Provided
Not Provided
Darshan Shah, M.D., East Tennessee State University
East Tennessee State University
Not Provided
Principal Investigator: Darshan S Shah, MD East Tennessee State University
East Tennessee State University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP