NCT04142099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

October 25, 2019

Last Update Submit

October 25, 2019

Conditions

Keywords

early maternal and child skin contact, neonatal sucking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • observational skin to skin contact start time in newborns sucking studies

    for 60 minute

Study Arms (2)

skin to skin contact 60 min group

EXPERIMENTAL

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

skin to skin contact 20 min group

ACTIVE COMPARATOR

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

Interventions

Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.

skin to skin contact 60 min group

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

skin to skin contact 20 min group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • weeks to 40 weeks of gestation
  • No high risk pregnancy
  • No nipple abnormality
  • Willing to breastfeed
  • Newborn weight 2500-4000 grams

You may not qualify if:

  • High risk pregnancy
  • weeks ago
  • Major bleeding during production
  • Neonatal life signs abnormality
  • Neonatal oral structure abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Infant Breastfeeding Assessment Tool Maternal Attachment Inventor Breastfeeding Mothers Social Support Scale Breastfeeding self-efficancy scale-short form
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital Hsin-Chu Branch

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

November 1, 2019

Last Updated

October 29, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations