Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study (TR-SSCinNICU)

This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation.

1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Enterocolitis; Breast Feeding; Retinopathy of Prematurity; Premature; Skin to Skin Contact
• Intervention / Treatment: Behavioral: skin to skin contact care

Detailed Description

1. Introduction: Throughout the historical evolution of the field of neonatology, negative consequences of newborns being separated from their families for extended periods while in neonatal intensive care units (NICUs) have been observed. In 1978, the concept of "Skin-to-skin care: Kangaroo Mother Care" was introduced. This model has been recommended by the World Health Organization to replace incubators and radiant warmer technologies in developing and least developed countries, where the capacity of NICUs is very limited. Additionally, in developed countries, where newborn health indicators are optimal, family-centered care and family-integrated care approaches have been used as crucial components to maintain the bond between mothers-and even families-with patients requiring NICU care and premature newborns. Canada in North America and Scandinavian countries in Europe are pioneers of this approach. In developed countries that have adopted this model, regardless of how small, premature, or ill the newborn is, their medical needs are met from birth while ensuring skin-to-skin care with their mother or father. In today's changing architecture of NICUs, care and treatment are conducted in "personalized neonatal intensive care areas for families," with the participation of families.

   Skin-to-skin care has been shown to be effective in improving breastfeeding rates, enhancing bonding, better physiological stability, reducing stress levels, shortening hospital stays, decreasing the risk of infections, lowering rates of intraventricular hemorrhage, and improving weight gain and parental confidence. Additionally, it has been shown to be most effective when skin-to-skin care is applied for more than one hour in a single session and for more than eight hours in a day. This can be best assured if a protocol exists in the units.

2. Objective: This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care application, which is initiated early and applied regularly, on clinical outcomes for preterm infants born at less than 32 weeks of gestation.

   1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
   2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.

3. Method: Eight training institutions (hospitals) from different geographical regions of Turkiye will be selected. Once the chair of the selected NICUs express their consent to participate, detailed information about the project will be provided to them. The training program developed regarding the skin-to-skin care approach will be delivered in a face-to-face format on a full training day for the responsible physicians and nursing staff working in the units. The theoretical lesson program will consist of three 45-minute lessons (history, standard skin-to-skin care application, skin-to-skin care application for at-risk infants). Practical lessons will be conducted in pairs using a realistic scenario with models. Following the theoretical and practical lessons, the aim is to implement skin-to-skin care based on a standardized protocol for at least one hour per each session, initiated early and regularly.

   a. The skin-to-skin care application proposed by the Turkish Neonatology Association is as follows:

   i. Duration: At least one hour per session

   ii. Time to initiate first skin-to-skin care:

   GA: < 28 weeks: After the 72nd hour GA: 28 - 32 weeks: As soon as stabilization is ensured

   iii. Criteria to accepted as stabilization: Absence of hypothermia Normal arterial tension with or without inotropic treatment Vital signs stable or easily normalized after nursing care Absence of frequent (>3/hour) and profound (any apnea requiring positive pressure ventilation in the last three hours) apnea

   b. Data Recording: Feeding details at discharge (Exclusive mothers'milk, ≥ 50% mothers' milk, < 50% mothers' milk, Formula) and data regarding outcomes (sepsis, intraventricular hemorrhage, necrotizing enterocolitis, duration of hospitalization) will be recorded for patients in the pre-education and post-education groups in each unit. The pre-education group includes infants discharged from the units in the two months prior to training, while the post-education group includes infants discharged from the units between the fourth and sixth months after training. Data collected before and after the intervention will be analyzed.

   c. Sample Size: To determine the sample size, a power analysis was conducted using the OpenEpi program. Assuming a 95% confidence level (1-α), an 80% test power (1-β), and an expected effect size of d=0.25, it was determined that at least 59 samples are required in each group.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sezin Unal, Prof, MD; Phone Number: 00905324008018; Email: sezinunal@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Baskent University
    • Contact: Sezin Unal; Phone Number: 0090532; Email: sezinunal@gmail.com
    • Principal Investigator: Canan SEREN, MD
    • Principal Investigator: Nejat NARLI, MD
    • Principal Investigator: Hilal Özkan, MD
    • Principal Investigator: Barış AKCAN, MD
    • Principal Investigator: Özge SERÇE PEHLİVAN, MD
    • Principal Investigator: Beyza ÖZCAN, MD
    • Principal Investigator: Ebru YÜCESOY BAĞDİKEN, MD
    • Principal Investigator: Gökçe ÇIPLAK, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants born at gestational age ≤ 32 weeks

Exclusion Criteria:

• Death before NICU discharge
• Abdominal wall defects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre education; The infants born at less than 32 weeks and discharged from the units in the last two months before training.
Active Comparator: Post education; The infants born at less than 32 weeks and discharged between four to six months after training	Behavioral: skin to skin contact care; Early and regular skin to skin contact in NICU GA: < 28 weeks: After the 72nd hour GA: 28 - 32 weeks: As soon as stabilization is ensured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers' Milk at Discharge	Number of infants receiving Exclusive Mothers' Milk at Discharge	Through study completion, an average of 3 months, at the time of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraventricular hemorrhage	Number of infants with intraventricular hemorrhage diagnosed by cranial ultrasound	Through study completion, an average of 3 months, at the time of discharge
Necrotizing enterocolitis (stage 2 and above)	Number of infants with necrotizing enterocolitis (stage 2 and above) according to Bell's criteria	Through study completion, an average of 3 months, at the time of discharge
Early neonatal sepsis	Number of infants with sepsis within first three days of admission; culture positive or clinical	Through study completion, an average of 3 months, at the time of discharge
Late neonatal sepsis	Number of infants with sepsis after the third day of admission; culture positive or clinical	Through study completion, an average of 3 months, at the time of discharge
Length of hospital stay	Total length of hospital stay	Through study completion, an average of 3 months, at the time of discharge

Collaborators and Investigators

• Sponsor: Baskent University Ankara Hospital
• Collaborators: Hacettepe University; Cukurova University; Gazi University; Baskent University; Marmara University; Ege University; Ondokuz Mayıs University; Kocaeli University; Uludag University; Ankara University; Trakya University; Aydin Adnan Menderes University; Cumhuriyet University; Umraniye Education and Research Hospital; Konya City Hospital; Sanliurfa Harran University
• Investigators: Study Chair: Esin Koc, Prof, MD, Gazi University; Study Director: Saadet Arsan, Prof, MD, Ankara University; Study Director: Hülya Bilgen, Prof, MD, Marmara University; Study Director: İlke Mungan Akın, Prof, MD, Umraniye Teaching and Research Hospital; Study Director: Betül Acunaş, Prof, MD, Trakya University; Study Director: Mehmet Yalaz, Prof, MD, Ege University; Study Director: Sezin Unal, Prof, MD, Baskent University; Study Director: Sule Yigit, Prof, MD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Retinopathy of Prematurity; Breast Feeding; Premature; Necrotizing Enterocolitis; Skin to skin contact
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Digestive System Diseases; Gastrointestinal Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Gastroenteritis; Premature Birth; Retinal Diseases; Retinopathy of Prematurity; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: TR-SSCinNICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No