INTRODUCTION:
Neonatal mortality accounts for two-thirds of the infant mortality rate in India and other developing countries. It is estimated that over 1 million newborn infants die during the first four weeks of life.
The current neonatal mortality rate in India is 39 per 1000 live births.1 Asphyxia was the single most important cause of still-births, accounting for 45.1% of all intrauterine deaths and the primary cause for neonatal mortality, accounting for 28.8% of all the deaths.2 Morbidity associated with perinatal asphyxia includes cerebral palsy, learning disabilities, visual and hearing impairments, behavioural abnormalities and residual motor or cognitive disabilities. These have a considerable effect on the surviving babies, their families and on society.
The etiology of perinatal Hypoxic Ischemic Encephalopathy (HIE) includes those conditions that can affect the cerebral blood flow in the fetus and newborn compromising the supply of oxygen to the brain. They may develop antepartum (20%), intrapartum (30%), intrapartum and antepartum (35%) or postpartum (10%). HIE that develops in the setting of perinatal asphyxia is part of a multiorgan system disease.
After an asphyxial event, there may be an opportunity to intervene to minimize brain damage. The first phase of brain damage, early cell death, results from the primary exhaustion of cellular energy stores.
Early cell death can occur within minutes. Damage to the brain is limited at this stage by immediate resuscitation to restore oxygen supply and blood circulation. A secondary phase of neuronal injury occurs some times after the initial insult. There are several mechanisms involved in this process.
Treatment during the post resuscitation phase aim to block these processes thereby limiting secondary cell damage and minimizing the extent of potential brain damage.
Neuroprotection was achieved in animal models of brain ischemia by reduction in brain temperature by 2°C to 5°C.6-11 Randomized control trials done in the developed countries using expensive equipment was shown to reduce mortality and morbidity among newborn survivors of perinatal asphyxia.12-17 The present trial was conducted to evaluate whether whole-body cooling could be achieved in a lowresource setting using simple available cooling materials.
AIM AND OBJECTIVES:
Aim and objectives:
To study the feasibility of whole body cooling for newborn infants with perinatal asphyxia in a low resource setting.
Primary objective:
Achievement of target temperature within 1 hour of initiation of treatment and within 6 hours of birth and maintaining the target temperature for 72 hours.
Secondary objectives:
Monitoring adverse events and possible complications that could occur secondary to whole body cooling.
1. Cardiac arrhythmia,
2. Persistent hypoxemia,
3. Hypotension despite full inotropic support,
4. Skin changes,
5. Thrombocytopenia,
6. Life threatening coagulopathy,
7. Arterial thrombosis,
8. Hepatic and renal failure,
9. Electrolyte disturbances,
10. Death.
METHODOLOGY:
Babies who were recruited into the trial included inborn (born at the Christian Medical College and Hospital) and outborn (born in a place other than the Christian Medical College and Hospital) admitted into the neonatal unit of the hospital.
Inclusion and exclusion criteria for Inborn babies.
Inclusion criteria:
1. Gestational age >35 wks,
2. pH 12 in umbilical cord arterial blood sample or postnatal ABG within firs hour of life AND,
3. Any two of the following,
4. Apgar score < 5 at 5 minutes,
5. Ventilation initiated at birth and continued for at least 10 minutes,
6. History of acute perinatal event (any one)
• Intrapartum fetal distress,
• Cord prolapse,
• Placental abruption,
• Maternal respiratory arrest,
• Uterine rupture / dehiscence.
Exclusion criteria:
1. Inability to start cooling the baby by 5.0 hours of age,
2. Small for gestational age babies (less than 10th centile for age),
3. Chromosomal abnormality,
4.Major congenital anomaly,
5. Refusal of consent for study participation.
Inclusion and Exclusion criteria for Outborn babies:
Inclusion criteria (all 3):
• Gestational age >35 wks.
• Babies who did not cry immediately after birth with any or all of the following features:
1. Not breathing normally at five minutes of birth,
2. Given assistance for breathing during or soon after birth,
3. Limp or flaccid since birth,
4. Not sucking well at the breast since birth without any oro-facial abnormality if documented by a pediatrician,
5. Apgar score of 5 or less at 5 minutes,
• Evidence of encephalopathy
Exclusion criteria:
1. Inability to start cooling the baby by 5.0 hours of age,
2. Small for gestational age babies (less than 10th centile for age),
3. Chromosomal abnormality,
4. Major congenital anomaly,
5. Refusal of consent for study participation.
CONCLUSIONS:
The conclusions of this feasibility trial are:
1. In a low resource setting, it is feasible to
• Obtain an informed consent and start the procedure within the acceptable time-frame of 6 hours following birth.
• Achieve a target rectal temperature within 6 hours of birth and 90 minutes of commencement of whole body cooling.
• Maintain the target rectal temperature for 72 hours.
2. Low-cost, easily available and reusable materials like cloth covered ice-gel packs are sufficient for achieving and maintaining the target rectal temperature.
3. Constant and careful monitoring of the skin temperature may be adequate in low resource centers.
4. There were only minimal serious adverse events during this procedure.
• Newborn infants who have deranged coagulation parameters with obvious signs of bleeding should probably be excluded from the cooling process
