Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

Premature Birth Clinical Trial

— MCSDDDFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980250
• Other study ID #: NFEC-2015-131
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2016
• Last updated: September 13, 2017
• Start date: November 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Weeks to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Domperidone Overdose
• Feeding Intolerance
• Gastric Retention
• Premature Birth

Intervention

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.
• 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.
• 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.
• Glucose
Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events		1 month
Primary	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	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