Table 4

Trials excluded from the analysis

Study

Description of the trial

Reason for exclusion


Akisu 2003 [26]

Randomized trial of 21 neonates with asphyxia, 10 assigned to head cooling for 72 h, 11 assigned to normothermia. Primary outcomes were electroencephalographic changes and concentrations of platelet activating factor in cerebrospinal fluid during the time of treatment

1. Enrolment based on presence of asphyxia only, not HIE*

2. Target temperature in hypothermia group 36.0–36.5°C

3. Time of start of intervention not standardized

4. No clinical follow-up data available

Zhou 2003 [27]

Randomized trial of 50 term neonates with asphyxia, 27 assigned to head cooling for 72 h, 23 assigned to normothermia. Primary outcomes were echocardiographic changes at the end of the intervention

1. Inclusion based on presence of asphyxia only, not HIE*

2. No clinical follow-up data available

Shao 2005 [28]

Multicenter randomized trial. 206 term neonates with HIE*, 127 allocated to head cooling via cooling cap for 72 h, 79 assigned to normothermia. Primary outcome was a composite of death or severe disability at 18 months

1. Concerns about randomization: Large difference in group sizes, method of randomization unknown, concealment of allocation unknown

2. Ongoing follow-up, currently 45% of survivors assessed at 18 months

Lin 2006 [29]

Singlecenter trial. 58 term neonates with HIE*, 30 assigned to head cooling via cooling cap for 72 h, 28 controls allocated to normothermia. Primary outcomes were changes on head computed tomography scans after one week and a behavioral assessment at 7–10 days

1. Not randomized, group allocation based on odd or even date of admission

2. Mean temperature in control group at begin of trial 35.7°C (all neonates outborn, no transport cot available), timing of enrolment and rewarming of control group unclear

3. No follow-up data available


* Hypoxic ischemic encephalopathy

Schulzke et al. BMC Pediatrics 2007 7:30   doi:10.1186/1471-2431-7-30

Open Data