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

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

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

Study Overview

• Status: Completed
• Conditions: Premature Birth; Feeding Intolerance; Gastric Retention; Domperidone Overdose
• Intervention / Treatment: Drug: Low dose; Drug: normal dose; Drug: over dose; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Nanfang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 5% Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the residual glucose percentage	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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of residual milk	the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.	7 days

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment-Emergent Adverse Events	1 month

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Shen-Zhen City Maternity and Child Healthcare Hospital; Guangzhou Panyu Central Hospital; Maternal and Child Health Hospital of Foshan; Guangdong Provincial Maternal and Child Health Hospital
• Investigators: Study Chair: WeiMing Huang, professor, Nanfang Hosiptal

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: premature infant; feeding intolerance; domperidone
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: NFEC-2015-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No