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Completed

NCT Number: NCT02980250

Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

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

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Key information

Age range

20 week–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dose

Drug

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

normal dose

Drug

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

over dose

Drug

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

Glucose

Drug

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

Primary outcomes

  1. the residual glucose percentage

    Time frame: 7 days

    3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube after 30 min

Secondary outcomes

  1. the percentage of residual milk

    Time frame: 7 days

    the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Guangdong Provincial Maternal and Child Health Hospital
  • Guangzhou Panyu Central Hospital
  • Maternal and Child Health Hospital of Foshan
  • Shen-Zhen City Maternity and Child Healthcare Hospital

Registry information

Official study title

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

Acronym: MCSDDDFI

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2016
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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