UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026483 |
|---|---|
| Receipt number | R000030419 |
| Scientific Title | A prospective multicenter randomized controlled trial for effect of gastric lavage on coffee ground emesis in neonates. |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2024/09/15 13:36:57 |
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Basic information
Public title
A prospective multicenter randomized controlled trial for effect of gastric lavage on coffee ground emesis in neonates.
Acronym
A trial for effect of gastric lavage on coffee ground emesis in neonates
Scientific Title
A prospective multicenter randomized controlled trial for effect of gastric lavage on coffee ground emesis in neonates.
Scientific Title:Acronym
A trial for effect of gastric lavage on coffee ground emesis in neonates
Region
| Japan |
Condition
Condition
coffee ground emesis in neonates
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to show that the gastric lavage for coffee ground emesis is effective against early establishment of nutrition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of neonates who show feeding intolerance within 24 hours from start of feeding
Key secondary outcomes
Body weight gain until 5th day after birth and babys checkup at one month
total amount of gastric residues within 24 hours from start of feeding
peak value of total bilirubin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gastric lavage with warm physiologic saline
Interventions/Control_2
No intervention
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 1 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonates who are admitted for repeating coffee ground emesis at 0days or 1day old.
Gestiational age:37weeks and 0day - 41weeks and 6days
Birth weight:2500-4000g
General conditions and vital signs are atable
Key exclusion criteria
Patients diagnosed with disease which needs surgical therapy (e.g. intestinal malrotation) or sustained bleeding, patients requiring for another therapy for asphyxia, infection, respiratory impairment or others, patients suspicious for another disease related to poor sucking or vomiting (e.g. 21 trisomy), or patients whose parents do not agree to participate in this study are excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sato |
Organization
Nagoya University Hospital
Division name
Division of Neonatology, Center for Maternal-Neonatal Care
Zip code
466-8560
Address
65 Tsurumai-cho Showa-ku, Nagoya, Japan
TEL
+81-(0)52-744-2294
yoshiaki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Maeda |
Organization
Ogaki city hospital
Division name
Department of Pediatrics
Zip code
503-8502
Address
4-86 Minaminokawa-cho Ogaki city, Gifu prefecture, Japan
TEL
+81-(0)584-81-3341
Homepage URL
takashimaeda19831228@gmail.com
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho Showa-ku, Nagoya 466-8560, Japan
Tel
+81-(0)52-744-2423
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030419
