- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04142099
Skin-to-Skin Contact Start Time in Newborns Sucking and Mother's Breastfeeding Willingness and Parent-Infant Attachment Associated
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To study the design of the mining experiment, the healthy full-term newborn and mother who gave birth by vaginal production in the delivery room of a teaching hospital in a northern region, and the maternal skin joints in the birth of the newborn, calculate the time to start execution, and According to the Infant Breastfeeding Assessment Tool (IBFAT), the time spent on spontaneous sucking behavior of newborns is estimated. The sample is estimated to take 20% sample loss rate. The number of cases received is 52 pairs. For 104 pairs, the researchers first filled 52 pairs of the control group and then received 52 pairs of the experimental group. The control group maintained routine treatment. The experimental group immediately contacted the mother and baby skin within 5 minutes of the birth of the newborn. The maternal and child skin contact process was carried out without forced or non-intervention, 48-72 hours after delivery.
The questionnaire was used to evaluate the mother's breastfeeding self-efficacy, breastfeeding social support, and maternal and child dependence relationships to estimate the difference. The results of the study will be based on the Generalized Estimating Equation (GEE) method to analyze the starting time of different groups of postpartum maternal and child skin contact, different time points for neonatal sucking ability, breastfeeding self-efficacy, breastfeeding social support, maternal and child Dependency changes.
On May 23, 2018, the researcher entered and left with the unit nursing director's promotion and consent, from June 1 to June 11.
In order to avoid interference with the interrogation of the subjects, the control group was first received and the experimental group was received. The control group of the pre-existing study was routine care, and no problems were found. The results of this experimental group showed that after the newborn was born, after 45 minutes of contact with the mother and baby, the milk-seeking reflex could occur and after 5 minutes. As a result of effective sucking, the mother expressed her happiness because of the sucking behavior of the newborn, and was willing to cooperate with the completion of the study to have the reference and basis before the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hsinchu, Taiwan, 300
- National Taiwan University Hospital, Hsin-Chu Branch
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Hsinchu, Taiwan
- National Taiwan University Hospital Hsinchu Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 37 weeks to 40 weeks of gestation
- No high risk pregnancy
- No nipple abnormality
- Willing to breastfeed
- Newborn weight 2500-4000 grams
Exclusion Criteria:
- High risk pregnancy
- 37 weeks ago
- Major bleeding during production
- Neonatal life signs abnormality
- Neonatal oral structure abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: skin to skin contact 60 min group
|
Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.
|
Active Comparator: skin to skin contact 20 min group
|
Newborns are exposed to maternal and child skin within five minutes of birth for 20 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
observational skin to skin contact start time in newborns sucking studies
Time Frame: for 20 minute
|
observational skin to skin contact start time in newborns sucking studies
|
for 20 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
observational skin to skin contact start time in newborns sucking studies
Time Frame: for 60 minute
|
observational skin to skin contact start time in newborns sucking studies
|
for 60 minute
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 107-061-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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