Skin-to-Skin Contact Start Time in Newborns Sucking and Mother's Breastfeeding Willingness and Parent-Infant Attachment Associated

October 25, 2019 updated by: IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
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.

Study Overview

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

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital, Hsin-Chu Branch
      • Hsinchu, Taiwan
        • National Taiwan University Hospital Hsinchu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
  1. Newborns are exposed to maternal and child skin within five minutes of birth.
  2. Observe the time of newborn spent in suctioning the maternal nipple in 60 minutes of skin to skin contact.
  3. No intervention or forced neonatal suction.
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
  1. Newborns are exposed to maternal and child skin within five minutes of birth.
  2. Observe the time of newborn spent in suctioning the maternal nipple in 20 minutes of skin to skin contact.
  3. No intervention or forced neonatal suction.
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

July 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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