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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04142099
Other study ID # 107-061-E
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date November 1, 2019

Study information

Verified date October 2019
Source National Taiwan University Hospital Hsin-Chu Branch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The maternal and child skin contact in the early postpartum period, so that the newborn can show effective sucking ability, will affect the self-confidence of the mother's feeding, and is also one of the factors affecting the mother's exclusive breastfeeding. The purpose of this study was to discuss the relationship between the onset of maternal and child skin contact and the relationship between neonatal milk, mother's willingness to breastfeed and parent-child attachment.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 104
Est. completion date November 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
skin to skin contact 60 min group
Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.
skin to skin contact 20min group
Newborns are exposed to maternal and child skin within five minutes of birth for 20 min.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Hsinchu Branch Hsinchu
Taiwan National Taiwan University Hospital, Hsin-Chu Branch Hsinchu

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary observational skin to skin contact start time in newborns sucking studies observational skin to skin contact start time in newborns sucking studies for 20 minute
Secondary observational skin to skin contact start time in newborns sucking studies observational skin to skin contact start time in newborns sucking studies for 60 minute