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

NCT06672913 | Recruiting

• 1 other identifier: TR-SSCinNICU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

Premature; Skin to skin contact; Breast Feeding; Necrotizing Enterocolitis; Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intraventricular hemorrhage

  Through study completion, an average of 3 months, at the time of discharge

• Necrotizing enterocolitis (stage 2 and above)

  Through study completion, an average of 3 months, at the time of discharge

• Early neonatal sepsis

  Through study completion, an average of 3 months, at the time of discharge

• Late neonatal sepsis

  Through study completion, an average of 3 months, at the time of discharge

• Length of hospital stay

  Through study completion, an average of 3 months, at the time of discharge

Study Arms (2)

Pre education

NO INTERVENTION

The infants born at less than 32 weeks and discharged from the units in the last two months before training.

Post education

ACTIVE COMPARATOR

The infants born at less than 32 weeks and discharged between four to six months after training

Behavioral: skin to skin contact care

Interventions

skin to skin contact care BEHAVIORAL

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

Post education

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants born at gestational age ≤ 32 weeks

You may not qualify if:

• Death before NICU discharge
• Abdominal wall defects

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead
• Ankara University: collaborator
• Gazi University: collaborator
• Hacettepe University: collaborator
• Marmara University: collaborator
• Umraniye Education and Research Hospital: collaborator
• Trakya University: collaborator
• Ege University: collaborator
• Ondokuz Mayıs University: collaborator
• Cukurova University: collaborator
• Sanliurfa Harran University: collaborator
• Cumhuriyet University: collaborator
• Uludag University: collaborator
• Kocaeli University: collaborator
• Aydin Adnan Menderes University: collaborator
• Konya City Hospital: collaborator
• Baskent University: collaborator

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth; Breast Feeding; Enterocolitis, Necrotizing; Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Esin Koc, Prof, MD

  Gazi University

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Sezin Unal, Prof, MD

CONTACT

00905324008018; sezinunal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD

Model Details: Multi-center, prospective pre and post training interventional clinical study. The effect of a standardized skin-to-skin contact application, which is initiated early and applied regularly, on clinical outcomes for preterm infants born at less than 32 weeks of gestation will be investigated. Intervention: Teoritical and practical education on skin to skin contact to ensure the application of Turkish Neonatal Society skin to skin contact protocol.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)