Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
NCT ID: NCT02980250
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
118 participants
INTERVENTIONAL
2015-11-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
low dose
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.
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
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.
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
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.
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.
placebo
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.
Glucose
Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* abdominal distention or vomiting;
* Reduce,delay or disruption of enteral feeding
Exclusion Criteria
* 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
20 Weeks
35 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Provincial Maternal and Child Health Hospital
OTHER
Shen-Zhen City Maternity and Child Healthcare Hospital
OTHER
Maternal and Child Health Hospital of Foshan
OTHER
Guangzhou Panyu Central Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Weimin Huang
The director of the neonatology department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
WeiMing Huang, professor
Role: STUDY_CHAIR
Nanfang Hosiptal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NFEC-2015-131
Identifier Type: -
Identifier Source: org_study_id