Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

NCT02980250 | Completed Phase 4 DMC

• 1 other identifier: NFEC-2015-131
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

Feeding Intolerance; Premature Birth; Domperidone Overdose; Gastric Retention

Keywords

feeding intolerance; premature infant; domperidone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the percentage of residual milk

  7 days

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1 month

Study Arms (4)

low dose

EXPERIMENTAL

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.

Drug: Low dose

normal dose

EXPERIMENTAL

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.

Drug: normal dose

over dose

EXPERIMENTAL

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.

Drug: over dose

placebo

PLACEBO COMPARATOR

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.

Drug: Glucose

Interventions

Low dose DRUG

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.

Also known as: Domperidone Suspension(Motilium), B12200018238

low dose

normal dose DRUG

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.

Also known as: Domperidone Suspension(Motilium), B12200018238

normal dose

over dose DRUG

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.

Also known as: Domperidone Suspension(Motilium), B12200018238

over dose

Glucose DRUG

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

Also known as: 5% Glucose

placebo

Eligibility Criteria

• Age: 20 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• the residual milk and glucose over 55%
• abdominal distention or vomiting;
• Reduce,delay or disruption of enteral feeding

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Guangdong Provincial Maternal and Child Health Hospital: collaborator
• Shen-Zhen City Maternity and Child Healthcare Hospital: collaborator
• Maternal and Child Health Hospital of Foshan: collaborator
• Guangzhou Panyu Central Hospital: collaborator

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Contraceptives, Oral; Glucose

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• WeiMing Huang, professor

  Nanfang Hosiptal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the neonatology department

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)