Table 2 Study characteristics clinical studies

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)