Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02980250

Acronym

MCSDDDFI

Enrollment

118

Registered

2016-12-02

Start date

2015-11-30

Completion date

2017-06-30

Last updated

2017-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Intolerance, Premature Birth, Domperidone Overdose, Gastric Retention

Keywords

feeding intolerance, premature infant, domperidone

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.

Interventions

DRUGLow 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.

DRUGnormal 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.

DRUGover 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.

DRUGGlucose

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Weeks to 35 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame
Incidence of Treatment-Emergent Adverse Events	1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026