Effect of skin-to-skin care compared with incubator care on cerebral oxygenation in preterm infants

Recruiting

• Conditions: Prematurity; Neurological - Studies of the normal brain and nervous system; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12616000240448
• Lead Sponsor: Royal Women's hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Preterm infants gestational age (GA) at birth less than 33 weeks
- No respiratory support
- No additional oxygen requirements
- Corrected age for prematurity < 36 weeks
- Parental written consent.
- Clinically stable infants (according to medical and nursing staff).

Exclusion Criteria

- Parents do not wish to have SSC
- First episode of SSC
- Respiratory support
- Infants who have:
- cerebral malformations
- severe hypoxia-ischaemia (Sarnat Stage III)
- post haemorrhage ventricular dilatation
- grade III-IV intraventricular haemorrhage
- treatment with inotropes
- umbilical catheters in situ

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). This is the only primary outcome. The mean regional cerebral oxygenation (rcO2) will be measured non-invasively by near-infrared spectroscopy (NIRS) (Fore-Sight Sensor, CAS Med. Medical Systems Inc., Branford, CT, USA)[1 hour of skin-to-skin care (intervention period) compared to 1 hour of incubator care (baseline period).]