Hypothermia During ECMO to Decrease Brain Injury

Withdrawn before enrolling · Not applicable

Conditions studied: Neonatal Respiratory Failure

In brief

Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.

Key facts

Study ID

NCT01675388

Run by

Sood, Beena G., MD, MS

People needed

0

Starts

2012-08-01

Expected to finish

2017-08-01

Last updated by the study team

2014-11-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates ≥ 34 weeks gestational age and postnatal age ≤ 28 days
• Presence of severe reversible NHRF qualifying for ECMO based on institutional guidelines including:
• Oxygenation Index > 35 ([mean airway pressure in cmH2O x Fractional inspired O2 concentration x 100]/Arterial O2 tension in mmHg) or
• Alveolar-arterial oxygen gradient > 600 mmHg for 4 h
• Infants undergoing veno-arterial or veno-venous ECMO

You may not qualify if…

• Lethal chromosomal and congenital anomalies including congenital diaphragmatic hernia (CDH) Infants with CDH, who constitute a third of neonates undergoing ECMO, have been excluded because the high mortality and morbidity is related more to the underlying lung abnormality and practice variation in timing of CDH repair rather than to NHRF.
• ECMO for post operative cardiac support
• Neonates with a birth weight < 1.8 kg
• Initiation of HYP for NE prior to initiating ECMO for NHRF

Where it is running

• Children's Hospital of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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