Trial | NCT02980250  Report issue

Title

Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    118
The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant
the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively .

An objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube. The residual percentage is the main result of the study.

The main result will be compared by the secondary result to help to explain the accuracy. The secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.

Any adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.
Study Started
Nov 30
2015
Primary Completion
May 31
2017
Study Completion
Jun 30
2017
Last Update
Sep 15
2017

Drug Low dose

0.2mg group-The premature infant will be fed with 0.2mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.

  • Other names: Domperidone Suspension(Motilium), B12200018238

Drug normal dose

0.4mg group-The premature infant will be fed with 0.4mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.

  • Other names: Domperidone Suspension(Motilium), B12200018238

Drug over dose

0.6mg group-The premature infant will be fed with 0.6mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.

  • Other names: Domperidone Suspension(Motilium), B12200018238

Drug Glucose

Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.

  • Other names: 5% Glucose

low dose Experimental

The premature infant in this group will be feed with 0.2mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.

normal dose Experimental

The premature infant in this group will be feed with 0.4mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.

over dose Experimental

The premature infant in this group will be feed with 0.6mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.

placebo Placebo Comparator

The premature infant in this group will be feed with some vitamin which will dilute into the 5% glucose and have the same appearance and taste with the experimental team for 7 days and will be tested the residual percentage everyday.

Criteria 

Inclusion Criteria:

the residual milk and glucose over 55%
abdominal distention or vomiting;
Reduce,delay or disruption of enteral feeding

Exclusion Criteria:

Four weeks before the start of this study had participated in other clinical trials
pulmonary hypertension;
Infants with necrotizing enterocolitis
Gastrointestinal tract malformation, congenital heart disease
Pre-existing QT extend/between long QT syndrome;
ascites
Have been used or will use drugs suppress CYP3A4
Other risk factors for prolong the QT
No Results Posted