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Multi-Center Study of Different Doses Domperidone in Feeding Intolerance (MCSDDDFI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980250
First Posted: December 2, 2016
Last Update Posted: September 15, 2017
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.
Collaborators:
Guangdong Provincial Maternal and Child Health Hospital
Shen-Zhen City Maternity and Child Healthcare Hospital
Maternal and Child Health Hospital of Foshan
Guangzhou Panyu Central Hospital
Information provided by (Responsible Party):
Weimin Huang, Nanfang Hospital of Southern Medical University
  Purpose
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

Condition Intervention Phase
Feeding Intolerance Premature Birth Domperidone Overdose Gastric Retention Drug: Low dose Drug: normal dose Drug: over dose Drug: Glucose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant

Resource links provided by NLM:


Further study details as provided by Weimin Huang, Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 month ]

Enrollment: 118
Study Start Date: November 2015
Study Completion Date: June 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low dose
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.
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 Name: Domperidone Suspension(Motilium), B12200018238
Experimental: normal dose
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.
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 Name: Domperidone Suspension(Motilium), B12200018238
Experimental: over dose
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.
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 Name: Domperidone Suspension(Motilium), B12200018238
Placebo Comparator: placebo
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.
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 Name: 5% Glucose

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   20 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT02980250


Locations
China, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangdong Provincial Maternal and Child Health Hospital
Shen-Zhen City Maternity and Child Healthcare Hospital
Maternal and Child Health Hospital of Foshan
Guangzhou Panyu Central Hospital
Investigators
Study Chair: WeiMing Huang, professor Nanfang Hosiptal
  More Information

Responsible Party: Weimin Huang, The director of the neonatology department, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02980250     History of Changes
Other Study ID Numbers: NFEC-2015-131
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weimin Huang, Nanfang Hospital of Southern Medical University:
feeding intolerance
premature infant
domperidone

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action