NCT05812222

Brief Summary

Breastfeeding is one of the most effective ways to ensure a baby's health and survival, and breast milk is the ideal food for babies. It is recommended to start breastfeeding within the first hour of life, following skin-to-skin contact between the mother and the newborn immediately after birth. Newborns transition from the dark, narrow and fluid-filled intrauterine environment to the wide, bright, cold and dry extrauterine life during the birth process. Thus, in addition to invasive procedures such as heel lance, vascular access, etc., including the birth process, simple and routine procedures such as separation from its mother in a short time to measure body weight cause stress for the newborn. For this reason, it is recommended that newborns should not be separated from their mothers except for important medical reasons, and that skin-to-skin contact should be initiated as soon as possible after birth so that the newborn can cope with the "birth stress". Hyperbilirubinemia, as physiological jaundice, usually begins in the first 24-72 hours of life in term newborns. It peaks in the following days and starts to decrease in the following days. Colostrum, which is a natural laxative found in breast milk, facilitates the removal of meconium in the newborn and provides bilirubin excretion with stool. With early skin-to-skin contact between mother and newborn in the first minutes of life after birth; Nurses have a key role in reducing the level of "birth stress" experienced by the newborn and in reducing the severity of hyperbilirubinemia by starting breastfeeding early.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

July 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

April 2, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

skin-to-skin contactnormal deliverystressbreastfeedingjaundice

Outcome Measures

Primary Outcomes (3)

  • The effect of early skin-to-skin contact applied immediately after normal delivery on the sucking efficiency of the newborn.

    "LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on sucking efficiency of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success. The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; \[L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)\]. The sucking efficiency of newborns was evaluated by the researcher with the "LATCH Breastfeeding Diagnostic Scale", 5 minutes after the initiation of early skin-to-skin contact immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth.

    through study completion, an average of 1 year

  • The effect of early skin-to-skin contact applied immediately after normal delivery on the stress level of the newborn.

    "Newborn Stress Scale" was used to determine the effect of skin-to-skin contact on after immediately normal delivery stress level of newborns. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the stress level of the newborn increases. The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods).

    through study completion, an average of 1 year

  • The effect of early skin-to-skin contact applied immediately after normal delivery on the bilirubin level of the newborn.

    Starting breastfeeding at least 5 minutes after the skin-to-skin contact application and feeding only with breast milk in the following days. The determination of feeding only breast milk and formula, body weight and total serum bilirubin level of a newborn brought to the hospital by her parents for routine control on the fifth day of life.

    through study completion, an average of 1 year

Study Arms (2)

intervention group (skin-to-skin contact group)

EXPERIMENTAL

Skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on. The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods). The suction sufficiency of newborns was evaluated by the investigator using the "LATCH Breastfeeding Assessment Tool", 5 minutes after the initiation of early SSC immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth.

Behavioral: Skin-to-Skin contact.

control group

NO INTERVENTION

The routine applications of the hospital were applied to the mothers and newborns in the control group. The stress level of newborns was determined immediately after birth, under a radiant heater, and during IM K vit injection (3 different time periods) using the "Neonatal Stress Scale". The suction sufficiency of newborns within the first hour after birth and 24 hours after birth was evaluated by the researcher using the "LATCH Breastfeeding Assessment Tool".

Interventions

Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on.

intervention group (skin-to-skin contact group)

Eligibility Criteria

Age2 Minutes - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • For mothers;
  • Vaginal delivery planning,
  • Be between the ages of 18-45,
  • Having a singleton pregnancy
  • Having completed the 37th week of gestation,
  • Agreeing to participate in the research,
  • Absence of breastfeeding barriers \[without human T-cell lymphotropic virus (HTLV-1), human Immunodeficiency virus (HIV) and active tuberculosis\]
  • Absence of any known health problems (such as diabetes, gestational diabetes, hypertension, Preeclampsia, renal failure, cardiac problems, psychiatric disorders)
  • There was no ABO and Rh incompatibility. For newborns;
  • Absence of conditions that prevent sucking such as frenulum or palate problem,
  • Absence of any health problems or congenital diseases,
  • Apgar Score ≥ 8
  • No need for resuscitation after birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingJaundice

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Intervention group and control group, randomized controlled, experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 13, 2023

Study Start

June 15, 2020

Primary Completion

September 15, 2020

Study Completion

March 31, 2021

Last Updated

July 20, 2023

Record last verified: 2023-03

Locations