UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048402 |
|---|---|
| Receipt number | R000044040 |
| Scientific Title | Comparison of tongue pressure and intra-oral pressure in mature and low birth weight infants-Focus on feeding disorder of low birth weight infants |
| Date of disclosure of the study information | 2022/07/19 |
| Last modified on | 2022/07/19 09:30:45 |
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Basic information
Public title
Comparison of tongue pressure and intra-oral pressure in mature and low birth weight infants-Focus on feeding disorder of low birth weight infants
Acronym
Comparison of tongue pressure and intra-oral pressure in mature and low birth weight infants-Focus on feeding disorder of low birth weight infants
Scientific Title
Comparison of tongue pressure and intra-oral pressure in mature and low birth weight infants-Focus on feeding disorder of low birth weight infants
Scientific Title:Acronym
Comparison of tongue pressure and intra-oral pressure in mature and low birth weight infants
Region
| Japan |
Condition
Condition
low birth weight infants
Classification by specialty
| Pediatrics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tongue pressure and intra-oral pressure in mature and low birth weight infants are measured, and the strength of adsorption and sucking is objectively evaluated and compared.
Basic objectives2
Others
Basic objectives -Others
To examine normal and cut-off values of tongue pressure and intra-oral pressure in neonate.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*tongue pressure
*intra-oral pressure
Key secondary outcomes
*Feeding amount
*Time required to take the prescribed amount
*State
* Existence of leakage of milk outside the mouth
*Employment of empty nipple
*SpO2
*Remaining stomach
*Number of continuous sucking
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Those who have started oral feeding in mature and low birth weight infants (weight 2,500 g or less at birth) who are hospitalized at this center
*Any gender
*A person who has given consent to this study from a parent or guardian
Key exclusion criteria
*Those who have organic or neurological problems with the swallowing organ
* Person wearing a ventilator
*Those who are judged unsuitable for examination by a doctor due to other serious complications
*Those who have not started oral feeding
* Those who have not given consent to this study from a parent or guardian
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Takeda |
Organization
National Center Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
1628655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
0332027181
mtakeda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
jufujita@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center Global Health and Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center Global Health and Medicine
Address
1-21-1, toyama, shinjuku-ku, Tokyo
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.go.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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 19 | 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
58
Results
The maximum tongue pressure and maximum oral pressure were significantly different between low birth weight infants and term infants.
A comparison of maximum tongue pressure and maximum oral pressure with and without feeding disorders in low birth weight infants
The maximum tongue pressure was significantly different between the group without feeding disorder and the group with feeding disorder, but no significant difference was observed in the maximum oral pressure.
Results date posted
| 2022 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Newborns born at the National Center for Global Health and Medicine
Participant flow
Participation in research with the consent of the mother
Adverse events
Outcome measures
*Birth weight
*Maximum oral pressure
*Maximum tongue pressure
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044040
