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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorBaskent University Ankara Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born at gestational age ≤ 32 weeks

Disqualifiers

Death before NICU discharge

Abdominal wall defects

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Pre educationNo intervention 0 interventions
Group B: Post educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mothers' Milk at Discharge

Number of infants receiving Exclusive Mothers' Milk at Discharge

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

Secondary outcomes

1

Intraventricular hemorrhage

Number of infants with intraventricular hemorrhage diagnosed by cranial ultrasound

Time frame
Through study completion, an average of 3 months, at the time of discharge
2

Necrotizing enterocolitis (stage 2 and above)

Number of infants with necrotizing enterocolitis (stage 2 and above) according to Bell's criteria

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

Early neonatal sepsis

Number of infants with sepsis within first three days of admission; culture positive or clinical

Time frame
Through study completion, an average of 3 months, at the time of discharge
4

Late neonatal sepsis

Number of infants with sepsis after the third day of admission; culture positive or clinical

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baskent University Ankara Hospital

Lead sponsor

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