The Effect of Early Skin-to-Skin Contact in Normal Births on Suction Sufficiency, Stress and Bilirubin Levels of Newborns
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedFirst Submitted
Initial submission to the registry
April 2, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedJuly 20, 2023
March 1, 2023
3 months
April 2, 2023
July 18, 2023
Conditions
Keywords
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)
EXPERIMENTALSkin-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.
control group
NO INTERVENTIONThe 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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- 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