Author and Year
|
Title
|
Nᶧ
|
Intervention Arm
|
Comparator Arm
|
Single/ Multiple Centre Trial
|
Age/ Weight Inclusion Criteria of Participants
|
Infant Age Group
|
Disease Area
|
Azzopardi
2009 (28)
|
Moderate hypothermia to treat perinatal asphyxial encephalopathy
|
325
|
Total body cooling and intensive care
|
Intensive care
|
Multiple
|
≥36 weeks gestation
|
Term
|
Neurological
|
Azzopardi
2014(29)
|
Effects of hypothermia for perinatal asphyxia on childhood outcomes
|
325
|
Standard care with hypothermia
|
Standard care
|
Multiple
|
≥36 weeks
|
Term
|
Neurological
|
Ballard
2006(30)
|
Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation
|
582
|
Nitric Oxide
|
Placebo
|
Multiple
|
<32 weeks
|
Preterm
|
Respiratory
|
Bassler
2015(31)
|
Early inhaled Budesonide for the prevention of bronchopulmonary dysplasia
|
856
|
Early inhaled budesonide
|
Placebo
|
Multiple
|
23+0 to 27+6 weeks+days
|
Preterm
|
Respiratory
|
Baud
2016(32)
|
Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre randomised trial
|
521
|
Hydrocortisone
|
Placebo
|
Multiple
|
24+0 to 27+6 weeks+days
|
Term
|
Respiratory
|
Beardsall
2008 (33)
|
Early insulin therapy in very-low-birth-weight infants
|
386
|
Early insulin
|
Standard neonatal care
|
Multiple
|
<1500g
|
Preterm
|
Other- Metabolic/ endocrine
|
Benjamin
2014 (34)
|
Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants, a randomized clinical trial
|
361
|
Fluconazole
|
Placebo
|
Multiple
|
<750g
|
Preterm
|
Infection
|
Brocklehurst
2011 (35)
|
Treatment of neonatal sepsis with intravenous immune globulin
|
3493
|
Polyvalent IgG immune globulin
|
Placebo
|
Multiple
|
<1500g
|
Preterm
|
Infection
|
Carlo
2010 (36)
|
Target ranges of oxygen saturation in extremely preterm infants
|
1316
|
Oxygen saturation 85-89%
|
Oxygen saturation 91-95%
|
Multiple
|
24+0 to 27+6 weeks+days
|
Preterm
|
Respiratory
|
Carr
2009 (37)
|
Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (PROGRAMS): a single-blind, multicentre randomised controlled trial
|
280
|
Granulocyte-macrophage colony stimulating factor
|
Standard care
|
Multiple
|
≤31 weeks
|
Preterm
|
Infection
|
Ceelie
2013 (38)
|
Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery
|
71
|
Continuous morphine
|
Intermittent intravenous paracetamol
|
Single
|
>36+1 week+days to 1 year
|
Term
|
Other- Pain
|
Costeloe
2016 (39)
|
Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial
|
1310
|
Probiotic B breve BBG-001
|
Placebo
|
Multiple
|
23+0 to 30+6 weeks+days
|
Preterm
|
Infection
|
Davidson
2016 (40)
|
Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial
|
719
|
Awake-regional anaesthesia
|
General anaesthesia
|
Multiple
|
≥26 weeks to 60 weeks
|
Both
|
Other- Sedation/ Anaesthesia
|
Fergusson
2012 (41)
|
Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth weight infants
|
377
|
Fresh red blood cell transfusions
|
Standard red blood cell transfusions
|
Multiple
|
<1250g
|
Preterm
|
Other- Haematological
|
Finer
2010 (42)
|
Early CPAP versus surfactant in extremely preterm infants
|
1316
|
Intubation and surfactant
|
Continuous positive airway pressure
|
Multiple
|
24+0 to 27+6 weeks+days
|
Preterm
|
Respiratory
|
Fivez
2016 (43)
|
Early versus late parenteral nutrition in critically ill children
|
1440
|
Late parenteral nutrition
|
Early parenteral nutrition
|
Multiple
|
Term newborns to 17 years
|
Term
|
Other- Nutrition
|
Gopel
2011 (44)
|
Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants: an open-label randomised, controlled trial
|
220
|
Surfactant without ventilation
|
Standard care
|
Multiple
|
26 to 28+6 weeks+days
|
Preterm
|
Respiratory
|
Harris
2013 (45)
|
Dextrose gel for neonatal hypoglycaemia (the Sugar Babies study): a randomised, double-blind, placebo-controlled trial
|
237
|
Dextrose gel
|
Placebo
|
Single
|
35 to 42 weeks
|
Both
|
Other- Metabolic/ endocrine
|
Hyttel-Sorenson
2015 (46)
|
Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial
|
166
|
Cerebral near infrared spectroscopy monitoring
|
Blinded near infrared spectroscopy monitoring
|
Multiple
|
<27+6 weeks+days
|
Preterm
|
Neurological
|
Kelleher
2013 (47)
|
Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial
|
488
|
Gentle wiping of the face, mouth and nose with a towel
|
Suction with a bulb syringe of the mouth and nostrils
|
Single
|
≥35 weeks
|
Both
|
Respiratory
|
Kimberlin
2011 (48)
|
Oral acyclovir suppression and neurodevelopment after neonatal herpes
|
74
|
Oral acyclovir
|
Placebo
|
Multiple
|
>800g
|
Both
|
Infection
|
Kimberlin
2015 (49)
|
Valganciclovir for symptomatic congenital cytomegalovirus disease
|
96
|
Valganciclovir therapy
|
Placebo
|
Multiple
|
≥32 weeks
|
Both
|
Infection
|
Kirpalani
2013 (50)
|
A trial comparing noninvasive ventilation strategies in preterm infants
|
1007
|
Nasal intermittent positive-pressure ventilation
|
Nasal continuous positive airway pressure
|
Multiple
|
<30 weeks and <1000g
|
Preterm
|
Respiratory
|
Leuchter
2014 (51)
|
Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age
|
165
|
Recombinant human erythropoietin
|
Placebo
|
Multiple
|
26 weeks to 31+6 weeks+days
|
Preterm
|
Neurological
|
Makrides
2009 (52)
|
Neurodevelopmental outcomes of preterm infants fed high-dose docosahexaenoic acid
|
657
|
High docosahexaenoic acid diet
|
Standard docosahexaenoic acid diet
|
Multiple
|
<33 weeks
|
Preterm
|
Other- Nutrition
|
Manley
2013 (53)
|
High-flow nasal cannulae in very preterm infants after extubation
|
303
|
High-flow nasal cannulae
|
Nasal continuous positive airway pressure
|
Multiple
|
<32 weeks
|
Preterm
|
Respiratory
|
Manzoni
2007 (54)
|
A multicentre, randomized trial of prophylactic fluconazole in preterm neonates
|
322
|
Fluconazole
|
Placebo
|
Multiple
|
<1500g
|
Preterm
|
Infection
|
Manzoni
2009 (55)
|
Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low birth weight neonates
|
472
|
Lactoferrin
|
Lactoferrin + Lactobacill-us rhamnosus GG
Placebo
|
Multiple
|
<1500g
|
Preterm
|
Infection
|
Mercier
2010 (56)
|
Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial
|
800
|
Inhaled nitric oxide
|
Placebo
|
Multiple
|
24+0 to 28+6 weeks+days
|
Preterm
|
Respiratory
|
Morley
2008 (57)
|
Nasal CPAP or intubation at birth for very preterm infants
|
610
|
CPAP
|
Intubation and ventilation at 5 minutes
|
Multiple
|
25+0 to 28+6 weeks+days
|
Preterm
|
Respiratory
|
Morris
2008 (58)
|
Aggressive vs conservative phototherapy for infants with extremely low birth weight
|
1974
|
Aggressive phototherapy
|
Conservative phototherapy
|
Multiple
|
501 to 1000g
|
Preterm
|
Other- Hepatic
|
Morris
2013 (59)
|
Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial
|
31
|
Percutaneous vesicoamniotic shunting
|
Conservative management
|
Multiple
|
No age or weight criteria
|
Both
|
Genitourinary
|
Moss
2006 (60)
|
Laparotomy versus peritoneal drainage for NEC and perforation
|
117
|
Primary peritoneal drainage
|
Laparotomy with bowel resection
|
Multiple
|
<34 weeks, <1500g
|
Preterm
|
Gastrointestinal
|
Natalucci
2016 (61)
|
Effect of early prophylactic high-dose recombinant human erythropoietin in very preterm infants on neurodevelopmental outcome at 2 years
|
365
|
Prophylactic early high-dose recombinant human erythropoietin (rhEPO)
|
Placebo
|
Multiple
|
26+0 to 31+6 weeks+days
|
Preterm
|
Neurological
|
Schmidt
2012 (62)
|
Survival without disability to age 5 years after neonatal caffeine therapy for apnea of prematurity
|
1640
|
Caffeine therapy
|
Placebo
|
Multiple
|
500g to 1250g
|
Preterm
|
Respiratory
|
Schmidt
2013 (63)
|
Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants
|
1201
|
Oxygen saturation 85% -89%
|
Oxygen saturation 91% - 95%
|
Multiple
|
23+0 to 27+6 weeks+days
|
Preterm
|
Respiratory
|
Shankaran
2012 (64)
|
Childhood outcomes after hypothermia for neonatal encephalopathy
|
190
|
Hypothermia
|
Usual care
|
Multiple
|
≥36 weeks
|
Both
|
Neurological
|
Shankaran 2014 (65)
|
Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy, a randomised clinical trial
|
364
|
32deg for 72h 33.5deg for 120h 32deg for 120h
|
33.5degrees for 72h
|
Multiple
|
≥36 weeks
|
Both
|
Neurological
|
Slater
2010 (66)
|
Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial
|
44
|
Sucrose solution
|
Sterile water
|
Single
|
37 to 43 weeks
|
Term
|
Other- Pain
|
Stenson
2013 (67)
|
Oxygen saturation and outcomes in preterm infants
|
2448
|
Oxygen saturation of 85-89%
|
Oxygen saturation of 91-95%
|
Multiple
|
<28 weeks
|
Preterm
|
Respiratory
|
Taddio
2006 (68)
|
Intravenous Morphine and topical tetracaine for treatment of pain in preterm neonates undergoing central line placement
|
132
|
Tetracaine or Morphine or Both
|
Neither Tetracaine nor Morphine
|
Multiple
|
No age or weight criteria
|
Both
|
Other- Pain
|
Tarnow-Mordi
2016 (69)
|
Outcomes of two trials of oxygen-saturation targets in preterm infants
|
1858
|
Lower oxygen-saturation range
|
Higher oxygen- saturation range
|
Multiple
|
<28 weeks
|
Preterm
|
Respiratory
|
Vaucher
2012(70)
|
Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial
|
990
|
Early CPAP with a limited ventilation strategy
|
Early surfactant administration
(2x2 factorial) Also to: 85-89% oxygen saturation or 91-95% oxygen saturation
|
Multiple
|
24+0 to 27+6 weeks+days
|
Preterm
|
Respiratory
|
Zivanovic
2014 (71)
|
Late outcomes of a randomized trial of high-frequency oscillation in neonates
|
319
|
High-frequency oscillatory ventilation
|
Conventional ventilation
|
Multiple
|
<29 weeks
|
Preterm
|
Respiratory
|
ᶧNumber of infants presenting baseline characteristics
|