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Table 2 Study characteristics clinical studies

From: Antileukotrienes for the prevention and treatment of chronic lung disease in very preterm newborns: a systematic review

  Cheng 2014 Kim 2015 Min Kim 2009 Panjwani 2016 Rupprecht 2014
Country Taiwan Korea Korea UK Germany, USA
Protocol registration Not reported NCT01717625 Not reported Not reported DRKS00004763
Study design Retrospective cohort Multicenter, prospective, randomized, open labelled, parallel group, intervention trial cohort study (preliminary investigation with the historical control group) cohort study (all infants received antileukotrienes) Unblinded, prospective trial (not-randomized)
Duration of follow-up Unclear. At least two years based on info from Table 3 (MDI and PDI) 36 weeks GA, or the discharge date 12 weeks Not reported Treatment was continued until the radiological signs and the clinical symptoms of BPD disappeared or discharge
Completeness of follow-up 4/4 Intervention group: 30/37
Control group 36/40
15/15 13/13 intervention group: 10/11 (1 died)
Control group: 4/11 (7 died)
Funding Not reported This study was supported by the research fund of the Korea Food and Drug Administration (KFDA) Not reported Not reported Partly funded by an unrestricted grant from the Oberfrankenstiftung, Bayreuth, Germany, which had no influence on the design, collection, analysis, or interpretation of data or publication
Mode of delivery Not reported Not reported INTERVENTION
VD 4, C-Sect. 11
CONTROL
VD 3, C-Sect. 12
Not reported Not reported
Type of control group No control group Unclear Standard treatment of BPD in the historical control group No control group Conventional therapy regimen
Total number of infants in intervention/control group 4 INTERVENTION
37
CONTROL
40
INTERVENTION
15
CONTROL
15
13 INTERVENTION
11
CONTROL
11
Gestational age Ranging 24–30 INTERVENTION
Mean 27.6 SD 1.6
CONTROL
Mean 27.3 SD 1.6
INTERVENTION
mean 27.3 SD 2.2 WEEKS
CONTROL
mean 27.1 SD 2.1 WEEKS
Mean gestation 25 + 3 weeks INTERVENTION
Mean 25.3 SD 1.6
CONTROL
Mean 25.6 SD 1.3
Birth weight Ranging 605–1490 g INTERVENTION:
1,097 SD 327
CONTROL:
997 SD 235
INTERVENTION
mean 913.7 SD 206.4
CONTROL
mean 982.7 SD 260.1
Mean birth weight 746 g INTERVENTION
Mean 658 SD 138
CONTROL
Mean 624 SD 144
Sex Not reported Not reported INTERVENTION
male 7, female 8
CONTROL
male 7, female 8
Not reported INTERVENTION
male 7, female 4
CONTROL
male, 7, female 4
Criteria (if any) to give intervention Montelukast was given as rescue therapy when the patients’ chest X-rays showed fibrosis or increased infiltration; or when the patient required higher or prolonged ventilator support, which was defined as FiO2 ≥ 30%, PIP ≥ 20 cm H2O and ventilator usage more than nine days  < 32 weeks, > 14 days old on O2 or mechanical ventilation; > 20 cal/kg/day by enteral feeding Existing BPD, admitted to the NICU except for cases where oxygen dependence other than lung diseases such as congenital anomalies, heart disease, and brain lesions may occur “Last resort” in infants with significant oxygen requirement and radiological changes of significant lung disease unresponsive to postnatal steroids Preterm infants with life-threatening BPD were chosen as the study group, with a probability of survival rated equal to or less than 50% by the attending physician. Further inclusion criteria for this study were a gestational age of less than 32 weeks, a birth weight of less than 1,500 g, and the need for mechanical ventilation support at day 28 after birth
Age when antileuk/comparator is given, Not reported. Infants seem to be a few weeks old because of the reported body weight when the intervention was administered INTERVENTION
31.3 SD 1.3
CONTROL
30.6 SD 1.6
Unclear Not reported Not clear. The recommended initiation of therapy was defined as the period between days 28 and 45 of life and as early as
possible
Name of antileukotriene/comparator Montelukast Montelukast Montelukast Sodium Montelukast Montelukast
Formulation Singulair Singulair Singulair Not reported Not reported
Initiation Not reported Not reported Not reported   1 mg/kg of body weight in the 1st week of therapy
Dose 2 mg According to body weight (less than 1,000 g, 0.5 mg; 1,000 g to 1,500 g, 1.0 mg; 1,500 g to 2,000 g, 1.5 mg; greater than 2,000 g, 2 mg) 1 mg/kg “2 mg/kg or 2 mg” (unclear reporting) 1 mg/kg of body weight in the 1st week of therapy, increasing to 1.5 mg/ kg of body weight in the 2nd week and finally to 2 mg/kg of body weight in the 3rd week
Frequency Once daily for at least 28 days Once daily until 36 weeks GA or until discharge Twice a day for the average of 12 weeks once daily single dose, daily
Route of administration Not reported Orogastric tube or by oral administration Orally Orally Not reported
Co-interventions Not reported Surfactant Standard treatment for BPD Not reported All infants had varying concomitant medications administered (e.g. methylxanthines, steroids, and diuretics)