A study about the use of whole body cooling for severe respiratory distress due to meconium aspiration syndrome (MAS) in neonates
| ISRCTN | ISRCTN10541833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10541833 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 21/11/2015
- Registration date
- 24/11/2015
- Last edited
- 04/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by lack of oxygen. Cooling (called whole body hypothermia [WBH]) is the standard treatment for newborn babies affected by HIE occurring at delivery. HIE is often associated with meconium aspiration syndrome (MAS), a severe respiratory problem that often occurs in newborns together with HIE. MAS occurs when a newborn baby breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery. The aim of this study is to clarify the effect of WBH on oxygenation and respiratory outcomes in MAS.
Who can participate?
Newborn babies with MAS born during 2006-2014 who were treated or not treated with WBH for HIE .
What does the study involve?
The clinical outcomes of babies who were treated with WBH are compared with the clinical outcomes of babies who were not treated with WBH.
What are the possible benefits and risks of participating?
There are neither benefits nor risks for participants.
Where is the study run from?
Eleven neonatal or pediatric intensive care units in Europe, Australia, South and North America. The study is being coordinated at the South Paris University Hospitals (France).
When is the study starting and how long is it expected to run for?
January 2006 to November 2015
Who is funding the study?
Not provided at time of registration
Who is the main contact?
Prof. Daniele De Luca
Contact information
Scientific
Service de Reanimation Neonatale
GHU Paris Sud
Hopital "A.Beclere"
157 rue de la Porte de Trivaux
Clamart (Paris)
92140
France
Study information
| Study design | International multicentre retrospective cohort study (observational) |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Whole body hypothermia and meconium aspiration syndrome: international multicentre retrospective cohort study |
| Study acronym | MASH (Meconium Aspiration Syndrome Hypothermia) |
| Study objectives | Whole body hypothermia might improve gas exchange and clinical outcomes in MAS patients, especially in those with more severe lung disease. |
| Ethics approval(s) | Ethical Committee of the French Society for Critical Care (SRLF), 19/11/2015, ref: 15/08 |
| Health condition(s) or problem(s) studied | Meconium aspiration syndrome |
| Intervention | The intervention being tested is whole body hypothermia. There are interesting animal and translational data suggesting the usefulness of whole body hypothermia for some forms of respiratory failure although this has never been studied on clinical grounds before. Conversely, hypothermia is already an established therapy for hypoxic ischemic encephalopathy (HIE). The study cohort consisted of babies affected by MAS and treated with whole body hypothermia (WBH) according to TOBY trial criteria for HIE (‘cooled’ neonates). The control cohort consisted of MAS babies with or without a diagnosis of HIE, in whom TOBY criteria were not met and WBH was not started (‘uncooled’ neonates) . |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Gas exchange over the first 72 hours of life (as described by oxygenation index, PaCO2 and pH) |
| Secondary outcome measures | 1. Duration of invasive mechanical ventilation 2. Total duration of respiratory support (defined as the total time spent under invasive, non-invasive ventilation, continuous positive airway pressure/high flow nasal cannulae and free oxygen therapy) 3. Length of stay in the intensive care unit 4. Length of hospital stay |
| Overall study start date | 01/01/2006 |
| Completion date | 01/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Pilot study (impossible to calculate given the lack of preliminary data on the topic) |
| Key inclusion criteria | Study cohort consisted of MAS neonates treated with WBH according to the TOBY trial criteria (see above). Control cohort consisted of MAS babies in whom TOBY criteria were not met and WBH was not instigated. All babies had to fulfill the following MAS diagnostic criteria: 1. Meconium-stained amniotic fluid 2. Need for intubation and tracheal suctioning in the delivery room according to the American Academy of Pediatrics neonatal resuscitation guidelines 3. Typical chest radiograph appearance 4. Oxygenation index (OI) > 10 at the intensive care unit admission |
| Key exclusion criteria | 1. Major congenital malformation or known chromosomal abnormalities 2. Any lung disease other than MAS 3. Need for extra-corporeal membrane oxygenation (ECMO) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Australia
- Brazil
- England
- France
- Italy
- Netherlands
- Spain
- United Kingdom
- United States of America
Study participating centres
Division of Pediatrics and Neonatal Critical Care
92140
France
TIN e TIP
00168
Italy
Royal Children’s Hospital
Department of Paediatrics
University of Melbourne
VIC 3052
Australia
1105 AZ
Netherlands
28029
Spain
OX39DU
United Kingdom
2565
Brazil
CA 94110
United States of America
Università degli Studi di Milano
20122
Italy
60123
Italy
United Kingdom
Sponsor information
Other
Prof. Marco Piastra
Terapia Intensiva Pediatrica (DEA)
Policlinico Univ."A. Gemelli"
Università Cattolica del Sacro Cuore
L.go A.Gemelli 8
Rome
00168
Italy
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Study results have been or will be (at least partially) presented at the main European meetings (ESPNIC 2015 and ESPR/jENS 2015) and at the Pediatric Academic Societies Meeting in the US (PAS/SPR 2015). During 2015/2016 a full paper should be sent for publication in a major international journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | Yes | No |
Editorial Notes
04/11/2016: Publication reference added.
