Cheng 2014 | Kim 2015 | Min Kim 2009 | Panjwani 2016 | Rupprecht 2014 | |
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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) |