Unique ID issued by UMIN | UMIN000029774 |
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Receipt number | R000034022 |
Scientific Title | Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial. |
Date of disclosure of the study information | 2017/11/01 |
Last modified on | 2022/02/20 19:04:03 |
Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial.
Sakae Infants and Mothers with Pediatric teLEconsultation (SIMPLE) study
Effectiveness of pediatric teleconsultation to reduce postpartum stress in mothers and to improve skin conditions in infants: a randomized controlled trial.
Sakae Infants and Mothers with Pediatric teLEconsultation (SIMPLE) study
Japan |
Parenting stress
Atopic dermatitis
Pediatrics | Dermatology | Psychiatry |
Adult | Child |
Others
NO
Evaluate the effectiveness of pediatric teleconsultation for reducing postpartum stress in mothers and preventing atopic dermatitis in infants
Efficacy
Exploratory
Pragmatic
Phase II,III
(1)Parenting Stress Index Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12) of mothers at the 4-month checkup
(2)Prevalence of atopic dermatitis of infants at the 4-month checkup
・Breastfeeding rates at the 4-month checkup
・Developmental Quotient (DQ) of infants at the 4-month checkup
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Educational,Counseling,Training
Other |
Interventions: Participants have an option to use the pediatric teleconsultation service from the registration to 4 months of age
Control: no interventions
Not applicable |
4 | months-old | > |
Male and Female
Pairs of mother and infant who will submit the birth card to Yokohama City Sakae Ward Office from November 1, 2017 to May 31, 2018
1. Unwillingness or inability to comply with the study requirements and procedures
2. Determined by study staff that either the mother or the infant may be adversely affected by participating in this trial
3. Mothers' inability to understand Japanese (communication through interpreter could be exceptional)
4. Infants born before 37 weeks of gestation
5. Infants born after 42 weeks of gestation
6. Twins or multiples
7. Infants needed neonatal intensive care
300
1st name | Tomohisa |
Middle name | |
Last name | Tomohisa |
National Center for Child Health and Development
Department of Health Policy
1578535
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
03-3416-0181
ando-tm@ncchd.go.jp
1st name | Tomohisa |
Middle name | |
Last name | Ando |
National Center for Child Health and Development
Department of Health Policy
1578535
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
03-3416-0181
simple-study@ncchd.go.jp
Department of Health Policy, National Center for Child Health and Development
None
Self funding
Japan
Yokohama City Sakae Ward Office
Kids Public Inc.
National Center for Child Health and Development
2-10-1 Okura, Setagaya-ku, 157-8535, Tokyo, Japan
03-3416-0181
hagino-k@ncchd.go.jp
NO
横浜市栄区(神奈川県)
2017 | Year | 11 | Month | 01 | Day |
none
Published
https://pediatrics.jmir.org/2022/1/e27615
278
The prevalence of atopic dermatitis in infants was significantly lower in the intervention group than in the control group during the 4-month checkup (20% vs 33%, P=.03; relative risk ratio, 0.614 [95% CI 0.406-0.927]). No significant differences were observed in the Parenting Stress Index-Short Form and General Health Questionnaire-12 scores between the 2 groups.
2022 | Year | 02 | Month | 20 | Day |
We detected no significant differences in their characteristics.
In total, 318 pairs of infants and mothers in the Yokohama City Sakae Ward were recruited when they submitted birth cards to the ward, received the explanation about the trial, and provided informed consent on the website for this trial. Eligible pairs of infants and mothers were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in the intervention and control groups received routine postnatal care from local government services. In addition, participants in the intervention group had the option to combine routine pediatric services with teleconsultation and email newsletters without charge from the date of registration until the infant turned 4 months.
There were no adverse events in this trial.
The primary outcomes were the prevalence of atopic dermatitis in infants, parenting stress, and mothers' mental health status at the 4-month checkup.
Secondary outcomes were breastfeeding rates and the developmental quotient of infants at the 4-month checkup.
Completed
2017 | Year | 10 | Month | 16 | Day |
2017 | Year | 10 | Month | 10 | Day |
2017 | Year | 11 | Month | 01 | Day |
2019 | Year | 02 | Month | 28 | Day |
2017 | Year | 10 | Month | 31 | Day |
2022 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022
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