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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980250
Other study ID # NFEC-2015-131
Secondary ID
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
Health authority
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

Study Design


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
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