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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23776115
Publication citations
-
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.