None listed
Conditions
Brief summary
Skin-to-skin contact (SSC) is defined as placing a baby prone directly onto their mother’s or father’s chest. SSC has advantages for newborn babies. It increases weight gain, reduces mortality, severe infection, and length of hospital stay. There are, however, conflicting results from studies, which measured physiological parameters (heart rate, breathing frequency and oxygen saturation) of preterm babies. Some studies showed an increase in oxygen desaturations and a decrease in regular breathing, others however a decrease in oxygen desaturations during SSC. This uncertainty is a barrier to implementation of SSC especially in very immature preterm babies. Both too much and too little oxygen supply to the brain contributes to morbidity and mortality in very preterm babies. Regional brain oxygenation (rcO2) can now be measured by a technology called near-infrared spectroscopy (NIRS). There is a lack of knowledge about brain oxygenation during SSC and there are no data in very preterm babies during their first days of life. If stability in rcO2 during SSC could be demonstrated this would provide reassurance that SSC is “safe” and could be used in immature babies who are receiving breathing assistance. The primary objective of this study is to measure rcO2 during SCC compared with measurements when the baby is being cared for in their incubator or cot. We aim to include 68 very preterm babies with a gestational age at birth less than 33 weeks receiving breathing assistance. We hypothesise that rcO2 remains stable during SSC (non-inferiority trial). The brain oxygen levels will not be visible to the medical and nursing staff. The primary outcome will be changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). Secondary outcome will be changes (mean of the differences) in physiological and ventilation parameters e.g. peripheral oxygen saturation (SpO2), fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, inspired oxygen (FiO2), heart rate (HR), and respiratory rate (RR), axillary body temperature between SSC (intervention) and incubator care (baseline), the number of hypoxemic (SpO2 less than 80%) and bradycardic episodes (bradycardia: fall in instantaneous HR by one third of the infants’ baseline HR lasting for at least 5 seconds between SSC (intervention) and incubator care (baseline), changes (mean of the differences) in rcO2, SpO2, fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, HR, RR, FiO2, number of hypoxemic and bradycardic episodes, axillary body temperature between post-intervention incubator care and pre-intervention incubator care (baseline) (1 hour period for each observation). Further sub group analysis will be changes (mean of the differences) in rcO2 obtained during washout period with those obtained during the main observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) obtained during feeding periods with the rest of the observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) between baseline and intervention period of ventilated infants with those from infants on CPAP and High-Flow nasal cannula.
Interventions
Skin-to-skin care (SSC), defined as placing a newborn prone directly onto their mother’s or father’s chest
a) duration: first 30 min of SSC will be defined as washout period and the subsequent 60 min of SSC will be used for the primary outcome. The duration of SSC will therefore last for at least 1.5 hours but might be continued as long as desired to avoid handling the preterm infants.
b) NIRS assessment: the regional cerebral oxygenation (rcO2) will be measured with a small Fore-Sight Sensor (
Skin-to-skin care (SSC), defined as placing a newborn prone directly onto their mother’s or father’s chest a) duration: first 30 min of SSC will be defined as washout period and the subsequent 60 min of SSC will be used for the primary outcome. The duration of SSC will therefore last for at least 1.5 hours but might be continued as long as desired to avoid handling the preterm infants. b) NIRS assessment: the regional cerebral oxygenation (rcO2) will be measured with a small Fore-Sight Sensor (CAS Med. Medical Systems Inc., Branford, CT, USA), which will be placed on the infant’s forehead underneath a CPAP hat. The sensor will be connected to the Fore-Sight device (CAS Med. Medical Systems Inc., Branford, CT, USA) and this will be connected to the monitor. Continuous data will be recorded. c) respiratory support: one of the inclusion criteria is that the infants need to receive some kind of respiratory support, either CPAP, High-Flow nasal cannula or ventilation via an endotracheal tube. All infants will stay on the same respiratory support during the three mentioned study periods: the baseline period (incubator care before intervention), intervention period (SSC) and post intervention period (incubator care after SSC). d) There are three observation periods mentioned above: 1. baseline period (control) 2. intervention period, 3. post-intervention period. Each period contains a 30 min washout period and a 60 min observation period. However, SSC might be continued as long as desired to avoid handling of the preterm infants. The recordings after the 60 min observation period will not be analysed for the primary outcome. e) The NISC nurse will organise and supervise the SSC and the unit protocol will be used to transfer and manage the infant during the SSC. The researchers will be responsible for the placement and management of the NIRS probe. No special training will be necessary for nurses looking after babies in the study, but in-servicing about the study will be provided. f) The researcher will stay on the bedside during the whole study time to record handling of the infant and other possible influencing factors.
Sponsors
The Royal Women's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
1 Days to 3 Months
Healthy volunteers
No
Inclusion criteria
- Preterm infants gestational age (GA) at birth less than 33 weeks receiving respiratory support (CPAP, High-Flow nasal cannula or ventilation via an endotracheal tube). - 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 - 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
Outcome results
None listed