Condition category
Neonatal Diseases
Date applied
21/11/2015
Date assigned
24/11/2015
Last edited
04/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Daniele De Luca

ORCID ID

Contact details

Service de Reanimation Neonatale
GHU Paris Sud
Hopital "A.Beclere"
157 rue de la Porte de Trivaux
Clamart (Paris)
92140
France

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 measures

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

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

Sponsor information

Organisation

Individual sponsor (Italy)

Sponsor details

Prof. Marco Piastra
Terapia Intensiva Pediatrica (DEA)
Policlinico Univ."A. Gemelli"
Università Cattolica del Sacro Cuore
L.go A.Gemelli 8
Rome
00168
Italy

Sponsor type

Other

Website

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

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27479063

Publication citations

Additional files

Editorial Notes

04/11/2016: Publication reference added.