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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Domperidone Overdose; Feeding Intolerance; Gastric Retention; Premature Birth

Treatments: Drug: Glucose; Drug: normal dose; Drug: over dose; Drug: Low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02980250

NFEC-2015-131

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 20 to 35 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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118 participants in 4 patient groups, including a placebo group

low dose

Experimental group

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.

Treatment:

Drug: Low dose

normal dose

Experimental group

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.

Treatment:

Drug: normal dose

over dose

Experimental group

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.

Treatment:

Drug: over dose

placebo

Placebo Comparator group

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.

Treatment:

Drug: Glucose