Skip to main content

Table 7 Outcomes of the 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
All-cause mortality (initial hospitalization) 0/6
Mortality seems not to be a prespecified outcome in this study, however no infants died
Not reported INTERVENTION: 0/15
CONTROL: not reported
3/13
(2 had an antenatal history of oligohydramnios)
INTERVENTION 1/11
CONTROL
7/11
BPD definition (NIH/Jobe / Walsh/unclear) Treatment study Jobe
INTERVENTION: mild 17/30; mod/severe 13/30
CONTROL: mild 17/36, mod/severe 19/36
NIH
INTERVENTION: mild 4/15 moderate 5/15 severe 6/15
CONTROL: mild 5/15 moderate 3/15 severe 7/15
Treatment study Treatment study
Harms Not reported INTERVENTION /
CONTROL
Infection: 8/3
Gastrointestinal disorders: 5/1
Blood and lymphatic system disorders: 2/1
Cardiac disorders: 1/0
General disorders and administration site conditions: 2/1
Hepatobiliary disorders: 1/0
Pregnancy, puerperium and perinatal conditions: 1/0
Renal and urinary disorders: 2/0
Respiratory, thoracic and mediastinal disorders: 1/1
Vascular disorders: 1/0
Investigations: 4/6
INTERVENTION/
CONTROL
Fever: 0/0
Diarrhea: 1/2
Cough: 0/0
Dermatatis: 0/0
Hypersensitivity reactions: 0/0
Vomiting symptoms: 0/0
t
“ No obvious side effects were noted” No drugs-
associated adverse events were identified; unclear about other adverse events
Hospital stay ranging 98–138 days     
All-cause neonatal mortality 0 Not reported Not reported Not reported Treatment study, no info about the time of drug administration
Respiratory support (duration, days) ranging 7–77 days Not reported Not reported mean ventilation days 41.4 (range 7–69) INTERVENTION: mechanical ventilation time: mean 41.2 SD 25.3 days
CONTROL: mechanical ventilation: 103.7 SD 90.6 days
Need for mechanical ventilation Not reported INTERVENTION: 7/37 at 2 weeks
CONTROL: 7/40 at two weeks
INTERVENTION:
before intervention: 11/15 after 2 weeks of montelukast 7
CONTROL:
before intervention: 11; after 2 weeks of montelukast 8
Not reported Not reported
Major neurodevelop-mental disability Mental developmental index at two years old: ranging 76–108
PDI at two years old: ranging 96–114
    
Retinopathy of prematurity 1 Not reported Not reported 8 Not reported
  1. None of the included studies reported on the following outcomes: FiO2 (duration, days), pulmonary function testing at school age