NCT03316716: NeoHyp

Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia

Completed NA Last updated 15 June 2018

What this trial tests

NA trial testing active warming in Neonatal Hypothermia in 150 participants. Completed in 31 May 2018.

Timeline

24 January 2018

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Aliona Vilinsky-Redmond
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	24 January 2018
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	1 location across Ireland

Drugs / interventions tested

• active warming

Conditions studied

• Neonatal Hypothermia — all drugs for Neonatal Hypothermia →

Sponsor

Aliona Vilinsky-Redmond

Who can join

Adults 18 to 50, female only, with Neonatal Hypothermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers on the new-born's temperature and general wellbeing. The two active warming methods recommended by NICE are the use of forced-air warming and fluid warmers.

Women's temperature tends to fall below the normal level (36.0oC to 37.5oC) during caesarean section if they have not been actively warmed during their operation (peri-operative). Peri-operative hypothermia may increase the morbidities experienced by women after caesarean section. While shivering is the most common postoperative incident, hypothermia may delay wound healing or increase the risk of wound infection, and can increase the risk of haemorrhage.

Neonatal hypothermia has a direct effect on the baby's cardiopulmonary, vascular system and central nervous system and increases the risks of mortality and morbidity. Specifically, neonatal hypothermia can lead to respiratory difficulties and apnoea, hypoxemia, carbon dioxide retention, metabolic acidosis, hypoglycaemia and decreased oxygen delivery to the tissues.

The absence of research and evidence on the effects of actively warming women undergoing caesarean section at term gestation on the temperature of new-borns during SSC means that further research is required.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.