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

Primary Purpose

Feeding Intolerance, Premature Birth, Domperidone Overdose

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Low dose
normal dose
over dose
Glucose
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Intolerance focused on measuring feeding intolerance, premature infant, domperidone

Eligibility Criteria

20 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

low dose

normal dose

over dose

placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 30, 2016
Last Updated
September 13, 2017
Sponsor
Nanfang Hospital, Southern Medical University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02980250
Brief Title
Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
Acronym
MCSDDDFI
Official Title
A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Intolerance, Premature Birth, Domperidone Overdose, Gastric Retention
Keywords
feeding intolerance, premature infant, domperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose
Arm Type
Experimental
Arm Description
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.
Arm Title
normal dose
Arm Type
Experimental
Arm Description
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.
Arm Title
over dose
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Low dose
Other Intervention Name(s)
Domperidone Suspension(Motilium), B12200018238
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal dose
Other Intervention Name(s)
Domperidone Suspension(Motilium), B12200018238
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
over dose
Other Intervention Name(s)
Domperidone Suspension(Motilium), B12200018238
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucose
Other Intervention Name(s)
5% Glucose
Intervention Description
Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
Primary Outcome Measure Information:
Title
the residual glucose percentage
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
the percentage of residual milk
Description
the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WeiMing Huang, professor
Organizational Affiliation
Nanfang Hosiptal
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

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