Feeding IntolerancePhase 4MCSDDDFINCT02980250
Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
A Phase 4 study testing Low dose, normal dose and over dose in people with Feeding Intolerance and Premature Birth, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 20 to 35 weeks
- Conditions the study is for
- Feeding Intolerance, Premature Birth, Domperidone Overdose
- What is being tested?
- Low dose, normal dose and over dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the residual milk and glucose over 55%
- abdominal distention or vomiting;
- Reduce,delay or disruption of enteral feeding
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
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
Read the 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.
- Being tested
- Low dose, normal dose, over dose, Glucose
- Keywords
- feeding intolerance, premature infant, domperidone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low doseDrug
Also called Domperidone Suspension(Motilium), B12200018238
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 doseDrug
Also called Domperidone Suspension(Motilium), B12200018238
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 doseDrug
Also called Domperidone Suspension(Motilium), B12200018238
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.
GlucoseDrug
Also called 5% Glucose
Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Maternal and Child Health Hospital, Shen-Zhen City Maternity and Child Healthcare Hospital, Maternal and Child Health Hospital of Foshan, Guangzhou Panyu Central Hospital
- Responsible party
- Principal investigator, Weimin Huang, Nanfang Hospital, Southern Medical University
- Investigators
- WeiMing Huang, professor, Study chair, Nanfang Hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980250
- Sponsor's protocol ID
- NFEC-2015-131
- Acronym
- MCSDDDFI
- Status last verified
- Sep 2017
- First submitted
- 30 Nov 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
- ClinicalTrials.gov ID
- NCT02980250
- Acronym / sponsor ID
- MCSDDDFI / NFEC-2015-131
- Keywords
- feeding intolerance, premature infant, domperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial Maternal and Child Health Hospital, Shen-Zhen City Maternity and Child Healthcare Hospital, Maternal and Child Health Hospital of Foshan, Guangzhou Panyu Central Hospital
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Drug: Low doseThe 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. |
| normal dose | Experimental | Drug: normal doseThe 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. |
| over dose | Experimental | Drug: over doseThe 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. |
| placebo | Placebo comparator | Drug: GlucoseThe 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. |
Who may qualify
- Ages
- 20 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- the residual milk and glucose over 55%
- abdominal distention or vomiting;
- Reduce,delay or disruption of enteral feeding
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low doseAlso: Domperidone Suspension(Motilium), B122000182380.2mg 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. | Drug | low dose |
| normal doseAlso: Domperidone Suspension(Motilium), B122000182380.4mg 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. | Drug | normal dose |
| over doseAlso: Domperidone Suspension(Motilium), B122000182380.6mg 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. | Drug | over dose |
| GlucoseAlso: 5% GlucoseGlucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period. | Drug | placebo |
Primary outcome
the residual glucose percentage
Time frame: 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
1 secondary outcome
the percentage of residual milk
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Feeding Intolerance
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FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
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Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WeiMing Huang, professor study chair
Nanfang Hosiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose, normal dose and over dose in people with Feeding Intolerance and Premature Birth, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the residual glucose percentage (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.