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

Summary

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.

Conditions

• Premature
• Skin to Skin Contact
• Breast Feeding
• Necrotizing Enterocolitis
• Retinopathy of Prematurity

Interventions

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

Sponsors & Collaborators

• Ankara University

  collaborator OTHER

• Gazi University

  collaborator OTHER

• Hacettepe University

  collaborator OTHER

• Marmara University

  collaborator OTHER

• Umraniye Education and Research Hospital

  collaborator OTHER_GOV

• Trakya University

  collaborator OTHER

• Ege University

  collaborator OTHER

• Ondokuz Mayıs University

  collaborator OTHER

• Cukurova University

  collaborator OTHER

• Sanliurfa Harran University

  collaborator UNKNOWN

• Cumhuriyet University

  collaborator OTHER

• Uludag University

  collaborator OTHER

• Kocaeli University

  collaborator OTHER

• Aydin Adnan Menderes University

  collaborator OTHER

• Konya City Hospital

  collaborator OTHER

• Baskent University

  collaborator OTHER

• Baskent University Ankara Hospital

  lead OTHER

Principal Investigators

• Esin Koc, Prof, MD · Gazi University

• Saadet Arsan, Prof, MD · Ankara University

• Hülya Bilgen, Prof, MD · Marmara University

• İlke Mungan Akın, Prof, MD · Umraniye Teaching and Research Hospital

• Betül Acunaş, Prof, MD · Trakya University

• Mehmet Yalaz, Prof, MD · Ege University

• Sezin Unal, Prof, MD · Baskent University

• Sule Yigit, Prof, MD · Hacettepe University

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-04-01

Completion

2025-06-01

Countries

• Turkey (Türkiye)

Study Locations