Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

Phase 4

Completed

• Conditions: Premature Birth; Domperidone Overdose; Feeding Intolerance; Gastric Retention
• Interventions: Drug: normal dose; Drug: over dose; Drug: Low dose; Drug: Glucose

• Registration Number: NCT02980250
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
normal dose	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.
over dose	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.
low dose	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.
placebo	Glucose	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.

Primary Outcome Measures

Name	Time	Method
the residual glucose percentage	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

Name	Time	Method
the percentage of residual milk	7 days	the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China