Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2.0
Study information
Scientific title
Whole body hypothermia and meconium aspiration syndrome: international multicentre retrospective cohort study
Acronym
MASH (Meconium Aspiration Syndrome Hypothermia)
Study hypothesis
Whole body hypothermia might improve gas exchange and clinical outcomes in MAS patients, especially in those with more severe lung disease.
Ethics approval
Ethical Committee of the French Society for Critical Care (SRLF), 19/11/2015, ref: 15/08
Study design
International multicentre retrospective cohort study (observational)
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2006
Overall trial end date
01/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Pilot study (impossible to calculate given the lack of preliminary data on the topic)
Participant 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)
Recruitment start date
01/01/2006
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Australia, Brazil, France, Italy, Netherlands, Spain, United Kingdom, United States of America
Trial participating centre
South Paris University Hospitals
Medical Center "A. Beclere"
Division of Pediatrics and Neonatal Critical Care
92140
France
Trial participating centre
Università Cattolica del Sacro Cuore
Policlinico Universitario "A. Gemelli"
TIN e TIP
00168
Italy
Trial participating centre
Murdoch Childrens Research Institute
Neonatology
Royal Children’s Hospital
Department of Paediatrics
University of Melbourne
VIC 3052
Australia
Trial participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Trial participating centre
NICU Hospital "La Paz"
Universidad Autonoma de Madrid
28029
Spain
Trial participating centre
John Radcliffe Hospital
Oxford University Hospitals NHS Trust
OX39DU
United Kingdom
Trial participating centre
University Hospital of University of São Paulo
Department of Pediatrics
2565
Brazil
Trial participating centre
San Francisco General Hospital
UCSF University of California
CA 94110
United States of America
Trial participating centre
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Department of Clinical Sciences and Community Health
Università degli Studi di Milano
20122
Italy
Trial participating centre
Women’s and Children Hospital "G. Salesi"
Polytechnical University of Marche
60123
Italy
Trial participating centre
University of Sheffield
S10 2TN
United Kingdom
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27479063