The Effect of Early Skin-to-Skin Contact in Normal Births on Suction Sufficiency, Stress and Bilirubin Levels of Newborns

Breastfeeding Clinical Trial

Official title:

The Effect of Early Skin-to-Skin Contact in Normal Births on Suction Sufficiency, Stress and Bilirubin Levels of Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812222
• Other study ID #: Nursing123456
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this study; The aim of this study is to examine the effect of early SSC applied after normal delivery on the newborn's sucking efficiency, postnatal stress and bilirubin levels.

Study hypotheses:

H1: Early skin-to-skin contact applied immediately after normal birth has an effect on the sucking efficiency of the newborn.

H2: Normal doğumdan hemen sonra uygulanan erken erken ten tene temasın yenidoğanın stres düzeyine etkisi vardır.

H3: Early skin-to-skin contact applied immediately after normal delivery has an effect on the newborn's bilirubin level.

Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Minutes to 5 Days

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breastfeeding
• Nurse's Role

Intervention

Behavioral:
• Skin-to-Skin contact.
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.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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