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

NCT ID: NCT06672913

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-01

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. 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pre education

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post education

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

Group Type: ACTIVE_COMPARATOR

skin to skin contact care

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Infants born at gestational age ≤ 32 weeks

Exclusion Criteria

• Death before NICU discharge
• Abdominal wall defects

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

Marmara University

OTHER

Sponsor Role: collaborator

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Trakya University

OTHER

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: collaborator

Ondokuz Mayıs University

OTHER

Sponsor Role: collaborator

Cukurova University

OTHER

Sponsor Role: collaborator

Sanliurfa Harran University

UNKNOWN

Sponsor Role: collaborator

Cumhuriyet University

OTHER

Sponsor Role: collaborator

Uludag University

OTHER

Sponsor Role: collaborator

Kocaeli University

OTHER

Sponsor Role: collaborator

Aydin Adnan Menderes University

OTHER

Sponsor Role: collaborator

Konya City Hospital

OTHER

Sponsor Role: collaborator

Baskent University

OTHER

Sponsor Role: collaborator

Baskent University Ankara Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sezin Unal

Prof, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esin Koc, Prof, MD

Role: STUDY_CHAIR

Gazi University

Saadet Arsan, Prof, MD

Role: STUDY_DIRECTOR

Ankara University

Hülya Bilgen, Prof, MD

Role: STUDY_DIRECTOR

Marmara University

İlke Mungan Akın, Prof, MD

Role: STUDY_DIRECTOR

Umraniye Teaching and Research Hospital

Betül Acunaş, Prof, MD

Role: STUDY_DIRECTOR

Trakya University

Mehmet Yalaz, Prof, MD

Role: STUDY_DIRECTOR

Ege University

Sezin Unal, Prof, MD

Role: STUDY_DIRECTOR

Baskent University

Sule Yigit, Prof, MD

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sezin Unal, Prof, MD

Role: CONTACT

sezinunal@gmail.com

00905324008018

Facility Contacts

Sezin Unal

Role: primary

sezinunal@gmail.com

0090532

Other Identifiers

TR-SSCinNICU

Identifier Type: -

Identifier Source: org_study_id