UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054360 |
|---|---|
| Receipt number | R000062092 |
| Scientific Title | Estimation of depth in the oral cavity at latching on during direct breastfeeding and bottle feeding |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/10 11:38:22 |
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Basic information
Public title
Estimating the latch-on depth during breastfeeding and bottle feeding in 1- to 4-months-old infants
Acronym
Study of estimating the latch-on depth
Scientific Title
Estimation of depth in the oral cavity at latching on during direct breastfeeding and bottle feeding
Scientific Title:Acronym
Study of latching on depth in the oral cavity
Region
| Japan |
Condition
Condition
None (Healthy Infants and mothers)
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the depth measurement of latch-on in the oral cavity and to compare longitudinal observations of breast-feeding and bottle-feeding.
Basic objectives2
Others
Basic objectives -Others
By understanding the adsorption depth characteristics of direct breastfeeding and bottle-feeding respectively, we support mothers and infants who use both direct breastfeeding and bottle-feeding.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective assessment
1)The depth measurement of latch-on
2)The angle measurement corner of mouth and mandibular
Key secondary outcomes
Subjective assessment
To evaluate latch-on and sucking behavior by mother and observer
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
| 1 | months-old | <= |
Age-upper limit
| 4 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Infants who are breast-feeding and bottle-feeding.
2)Infants who are before eruption of deciduous tooth and not start baby food.
3)Mothers and infants without special medical intervention.
4)Mothers and infants who agree to join our observation.
Key exclusion criteria
Infants who were out of the infant development curve and those diagnosed with oral abnormalities were excluded from this observation.
The reason for exclution is that we consider physical development and oral characteristics to be relevant to the sucking behavior.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Kuroishi |
Organization
Pigeon Corporation
Division name
Research and Development DIV.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL
0297-52-6532
sumiko.kuroishi@pigeon.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Abe |
Organization
Pigeon Corporation
Division name
Research and Development DIV.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL
0297-52-6532
Homepage URL
akiko.abe@pigeon.com
Sponsor or person
Institute
Pigeon Corporation
Institute
Department
Personal name
Funding Source
Organization
Pigeon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ryoukan Kids Family Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.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
ピジョン株式会社中央研究所（茨城県）
Central Research Institute Pigeon Corporation（Ibaraki Pref.）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://store.medica.co.jp/item/130012405
Publication of results
Published
Result
URL related to results and publications
https://store.medica.co.jp/item/130012405
Number of participants that the trial has enrolled
6
Results
Latch-on depth and mouth angle did not differ significantly among ages nor feeding format. The mandibular angle was significantly smaller at age 4 months in the breast-feeding group; however, it did not change with age in the bottle-feeding group.
Although two calculation methods were planned for the depth of adsorption, only the method was used . Because another method calculated not using ultrasound images was difficult to estimate intraoral the depth of latch-on.
Results date posted
| 2024 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
The 9 pairs of participants, 6 pairs for which data were available from 1 to 4 months of age were included in the analysis, excluding 3 pairs of mothers and infants: 1 pair with missing observation data and 2 pairs who declined participation (e.g., because the bottle feeding was no longer needed; Declined due to COVID-19).
Participant flow
We recruited mothers of 1-month-old who had registered for Pigeon product tester.
Adverse events
None
Outcome measures
Objective assessment
1)The depth measurement of latch-on
2)The angle measurement corner of mouth and mandibular
Subjective assessment
Evaluation of latch-on and sucking behavior by mother and observer
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Within subjects design
Longitudinal study
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062092
