Condition category
Pregnancy and Childbirth
Date applied
31/01/2011
Date assigned
03/03/2011
Last edited
04/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Should exothermic mattresses be used in combination with polyethylene bags to prevent heat loss in preterm infants at birth? (bag and mattress or bag in the delivery room): a randomised controlled trial

Acronym

The Bambino Trial

Study hypothesis

For newborn infants less than 31 weeks nursed in polyethylene bags under radiant heat, the use of exothermic mattresses results in more infants with admission temperatures outside the normal range (core temperature 36.5 - 37.5°C).

Ethics approval

Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd December 2010

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prematurity/prevention of hypothermia in newborns

Intervention

Infants in both groups will be placed in a polyethylene bag and placed under radiant heat after birth. Infants randomised to the "bag" group will receive no additional measures to provide heat. Infants randomised to "mattress group" will, in addition, be placed on an exothermic chemical mattress (TransWarmer® Infant Transport Mattress, Cooper Surgical Inc., Trumbull CT, USA) which will be activated before delivery.

The primary outcome for this trial is the infant's core (rectal) temperature on admission to the neonatal intensive care unit. All infants will be followed until hospital discharge.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Core temperature 36.5 - 37.5°C on admission to the Neonatal Intensive Care Unit (NICU)

Secondary outcome measures

1. Apgar scores at 5 and 10 minutes
2. Positive pressure ventilation (PPV) in the delivery room (DR)
3. Intubation and mechanical ventilation in the DR
4. Supplemental oxygen in the DR
5. Chest compressions in the DR
6. Use of adrenaline and volume resuscitation in the DR
7. Time to NICU admission
8. Intubation and mechanical ventilation during hospital stay
9. Duration of oxygen therapy (hours and days)
10. Oxygen therapy at 28 days
11. Oxygen therapy at 36 weeks' corrected gestational age
12. Sepsis – early and late onset
13. Patent ductus arteriosus
14. Intraventricular haemorrhage
15. Periventricular leukomalacia
16. Necrotising Enterocolitis
17. Hospital days
18. Death before hospital discharge

Overall trial start date

11/01/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born at the National Maternity Hospital (NMH) at less than 31 weeks gestation by best obstetric estimate

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

116

Participant exclusion criteria

Known congenital anomaly with an open lesion (e.g. gastroschisis or myelomeningocele)

Recruitment start date

11/01/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Ireland

Trial participating centre

Neonatal Intensive Care Unit
Dublin
2
Ireland

Sponsor information

Organisation

The National Children's Research Centre (Ireland)

Sponsor details

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland

Sponsor type

Research organisation

Website

http://www.nmh.ie/iopen24/index.php

Funders

Funder type

Research organisation

Funder name

The National Children's Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23776115

Publication citations

  1. Results

    McCarthy LK, Molloy EJ, Twomey AR, Murphy JF, O'Donnell CP, A randomized trial of exothermic mattresses for preterm newborns in polyethylene bags., Pediatrics, 2013, 132, 1, e135-41, doi: 10.1542/peds.2013-0279.

Additional files

Editorial Notes