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

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ClinicalTrials.gov Identifier: NCT04142099
Recruitment Status : Active, not recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch

Brief 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.

Condition or disease Intervention/treatment Phase
Mother-Child Relationship Behavioral: skin to skin contact 60 min group Behavioral: skin to skin contact 20min group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Infant Breastfeeding Assessment Tool Maternal Attachment Inventor Breastfeeding Mothers Social Support Scale Breastfeeding self-efficancy scale-short form
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Skin-to-Skin Contact Start Time in Newborns Sucking and Mother's Breastfeeding Willingness and Parent-Infant Attachment Associated
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142099


Locations
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Taiwan
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, Taiwan, 300
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital Hsin-Chu Branch

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Responsible Party: IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
ClinicalTrials.gov Identifier: NCT04142099     History of Changes
Other Study ID Numbers: 107-061-E
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch:
early maternal and child skin contact, neonatal sucking