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Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial (HELIX)

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ClinicalTrials.gov Identifier: NCT02387385
Recruitment Status : Recruiting
First Posted : March 13, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Madras Medical College
Manipal Hospital, India
Indira Gandhi Medical College
Lokmanya Tilak Municipal Medical College and Hospital
Imperial College London
Maulana Azad Medical College
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
University of Kelaniya
Medical College Trivandrum
Information provided by (Responsible Party):
Thayyil, Sudhin

Brief Summary:

Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately one million babies die from neonatal encephalopathy in low and middle-income countries and a quarter of these deaths occur in India.

In the past decade, a number of clinical trials in high-income countries has shown that cooling therapy along with optimal neonatal intensive care reduces death and neurodisability after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after neonatal encephalopathy in all high income countries, including the UK.

Although the burden of neonatal encephalopathy is far higher in low and middle-income countries, the safety and efficacy data on cooling therapy from high income cooling trials cannot be extrapolated to these settings, due to the difference in population co-morbidities and sub-optimal neonatal intensive care.

The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6 hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after neonatal encephalopathy in public sector neonatal units in India.

A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from the participating centres in India over an 18 to 24 month period. The babies will be randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved using an approved cooling device (Tecotherm) that is already in clinical use in the UK and in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is death or moderate/severe neurodisability at 18 months.


Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Device: Whole body cooling (Tecotherm) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial
Study Start Date : August 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Intervention
Whole body cooling to 33 degrees C to 34 degrees C
Device: Whole body cooling (Tecotherm)
Whole body cooling to 33 to 34 C using Tecotherm

No Intervention: Standard of Care
Standard of care



Primary Outcome Measures :
  1. Composite outcome of Death or moderate or severe neurodisability [ Time Frame: 18 to 22 months ]

Secondary Outcome Measures :
  1. Mortality from any cause [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  2. Major intracranial haemorrhage [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  3. Gastric bleeds (fresh blood > 5 ml from nasogastric tube) [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  4. Persistent hypotension (mean blood pressure < 40 mm of Hg requiring inotropic support) [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  5. Pulmonary haemorrhage (Copious bloody secretions with clinical deterioration requiring change(s) in ventilatory management) [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  6. Persistent pulmonary hypertension (Severe hypoxemia disproportionate to the severity of lung disease with a significant pre-and post ductal saturation difference on pulse oximetry) [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  7. Prolonged blood coagulation time requiring blood products [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  8. Culture proven early onset sepsis (isolation of a pathogenic organism from blood or cerebrospinal fluid along with clinical evidence of sepsis and elevation of C-reactive protein) [ Time Frame: Prolonged blood coagulation time requiring blood products Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  9. Necrotising enterocolitis (defined as abdominal distension, increased gastric aspirates and/or blood in stools together with abdominal X-ray showing bowel oedema, pneumatosis or pneumoperitoneum, i.e. Bell's staging 2 or 3) [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  10. Cardiac arrhythmia [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  11. Severe thrombocytopenia [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  12. Renal failure [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  13. Pneumonia [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  14. Subcutaneous fat necrosis [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  15. Duration of hospitalisation [ Time Frame: before discharge from hospital Expected average of 3 weeks ]
    Expected average of 3 weeks hospital stay

  16. Mortality [ Time Frame: Long term (18 to 22 months) ]
    Expected average of 3 weeks hospital stay

  17. Severe neurodevelopmental disability [ Time Frame: Long term (18 to 22 months) ]
  18. Microcephaly (head circumference more than 2 standard deviations below the mean) [ Time Frame: Long term (18 to 22 months) ]


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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age < 6 hours, Birth-weight >1.8 kg, Gestation >36 weeks
  2. Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score <6 (in babies born at hospital) or lack of cry by 5 minutes of age (for babies born at home)
  3. Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.

Exclusion Criteria:

  1. Absent heart rate at 10 minute of age despite adequate resuscitation.
  2. Major life threatening congenital malformation.
  3. Migrant family or parents unable/unlikely to come back for follow up at 18 months.
  4. Lack of parental consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387385


Contacts
Contact: Sudhin Thayyil, PhD 02033132488 s.thayyil@imperial.ac.uk
Contact: Vania P Oliveira, MSc 02033132488 v.oliveira@imperial.ac.uk

Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh, 1000
Contact: Mohammed Shahidullah, MD    02 9668785    shahidullahdr@gmail.com   
India
Institute of Obstetrics and Gynaecology Recruiting
Chennai, TamilNadu, India
Contact: Aresar Sreelar, MD         
Contact: Prakash Vinayagam, MD         
Indira Gandhi Institute of Child Health Recruiting
Bangalore, India
Contact: Naveen Benkappa, MD         
Contact: Prathik Bandya, MD         
Calicut Medical College Not yet recruiting
Calicut, India
Contact: Vijayakumar Madhavan, MD         
Contact: Aslam PK, MD         
Institute of Child Health, Madras Medical College Recruiting
Chennai, India
Contact: Mangal Bharathi, MD         
Principal Investigator: Mangal Bharathi, MD         
Sub-Investigator: Kamal Ratnam, MD         
Sion Hospital Recruiting
Mumbai, India
Contact: Jayashree Mondhkar, MD         
Contact: Swati Manerkar, MD         
Maulana Azad Medical College Recruiting
New Delhi, India
Contact: Sidharth Ramji, MD         
Medical College Trivandrum Recruiting
Trivandrum, India
Contact: Radhika Ajith, MD       radhikaajith@gmail.com   
Contact: Sobha Kumar, MD       dr.sobhakumar@gmail.com   
Sri Lanka
University of Kelaniya Recruiting
Kelaniya, Sri Lanka
Contact: Ranmali Rodrigo, MD       ranmali_waduge@yahoo.com   
Sponsors and Collaborators
Thayyil, Sudhin
Madras Medical College
Manipal Hospital, India
Indira Gandhi Medical College
Lokmanya Tilak Municipal Medical College and Hospital
Imperial College London
Maulana Azad Medical College
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
University of Kelaniya
Medical College Trivandrum
Investigators
Study Director: Sudhin Thayyil, PhD Imperial College London
Principal Investigator: Pete Lally, MPhys Imperial College London
Principal Investigator: Mani Chandrasekharan, MD Imperial College London
Principal Investigator: Ravi Swamy, MD Imperial College London
Principal Investigator: Vania Oliveira, MSc Imperial College London
Principal Investigator: Seetha Shankaran, MD Wayne State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT02387385     History of Changes
Other Study ID Numbers: 15HH
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Hypothermia
Brain Diseases
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases