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TABLE 1

Research Questions (24) for Care of the Preterm or LBW Infant

InterventionsPICO
Thermal care  
 Kangaroo mother care (KMC) In preterm or LBW infants (P), what is the effect of KMC (I) compared with conventional neonatal care (C) on critical outcomes (O)? If KMC is effective, then what is the effect of early‐onset KMC (I) compared with late‐onset KMC (C) on critical outcomes (O)? What is the effect of short (I) compared with longer (C) durations of KMC on critical outcomes (O)? 
Milk feeding  
 Mother’s own milk In preterm or LBW infants (P), what is the effect of feeding mother's own milk (I) compared with feeding infant formula (C) on critical outcomes (O)? 
 Donor human milk In preterm or LBW infants who cannot be fed mother's own milk (P), what is the effect of feeding donor human milk (I) compared with feeding infant formula (C) on critical outcomes (O)? 
 Infant formula In preterm or LBW infants who cannot be fed mother's own milk or donor human milk (P), what is the effect of feeding nutrient enriched (‘preterm’) infant formula (I) compared with feeding standard infant (“term”) formula (C) on critical outcomes (O)? 
 Fortification In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of multicomponent fortification of milk (I) compared with no fortification (C) on critical outcomes (O)? 
 Initiation of enteral feeding In preterm or LBW infants (P) what is the effect of early initiation of enteral feeding (I) compared with delayed feeding (C) on critical outcomes (O)? If early, then when should feeding be initiated? Does this effect differ in infants given full enteral feeding compared with infants given restricted volumes including minimal enteral feeding? 
 Responsive feeding In preterm or LBW infants who receive any enteral feeding (P), what is the effect of responsive feeding based on infants’ cues (I) compared with scheduled feeding (C) on critical outcomes (O)? 
 Volume advancement In preterm or LBW infants who receive any enteral feeding (P), what is the effect of fast advancement of enteral feeds (I) versus slower rates of feed advancement (C) on critical outcomes (O)? 
 Duration of exclusive breastfeeding In preterm or LBW infants (P), what is the effect of exclusive breastfeeding for less than 6 mo (I) compared with exclusive breastfeeding for 6 mo (C) on critical outcomes (O)? If less than 6 mo, then what is the optimal duration? 
Micronutrients  
 Iron In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral iron supplementation (I) compared with no iron supplementation (C) on critical outcomes (O)? 
 Zinc In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral zinc supplementation (I) compared with no zinc supplementation (C) on critical outcomes (O)? 
 Vitamin D In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral vitamin D supplementation (I) compared with no vitamin D supplementation (C) on critical outcomes (O)? 
 Vitamin A In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral vitamin A supplementation (I) compared with no vitamin A supplementation (C) on critical outcomes (O)? 
 Calcium and phosphorous In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral CaP04 supplementation (I) compared with no CaP04 supplementation (C) on critical outcomes (O)? 
 Multiple micronutrient supplements In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral multiple micronutrient supplements (I) compared with no enteral multiple micronutrient supplements (C) on critical outcomes (O)? 
Probiotics  
 Probiotics In preterm or LBW infants who receive any enteral feeding (P), what is the effect of probiotics (I) versus no probiotics (C) on critical outcomes (O)? 
Skin care  
 Emolients In preterm or LBW infants (P) what is the effect of topical ointment, cream or oil applied to the skin (I) compared with routine skin care (C) on critical outcomes (O)? 
CPAP respiratory support  
 CPAP for respiratory distress In preterm infants with respiratory distress syndrome (P), what is the effect of any CPAP therapy (I) versus supportive care with oxygen therapy by head box, facemask, or nasal cannula (C) on critical outcomes (O)? 
 Early CPAP In preterm infants with respiratory distress syndrome (P), what is the effect of early CPAP (I) versus late CPAP(C) on critical outcomes (O)? 
 CPAP prophylaxis In preterm infants less than 32w regardless of respiratory status (P) What is the effect of CPAP started immediately after birth (I) compared with supportive care with oxygen therapy by head box, face mask, or nasal cannula (C) on critical outcomes (O)? -what is the effect of CPAP started immediately after birth (I) compared with mechanical ventilation (C) on critical outcomes (O)? 
 CPAP pressure source In preterm infants with respiratory distress syndrome, what is the effect of bubble (I) compared with other forms of CPAP (C) on critical outcomes (O)? 
Methyl xanthine respiratory management  
 Methyl xanthines In preterm infants, what is the effect of any methyl xanthine compared with no methyl xanthine on critical outcomes? What is the effect by indication (any, prevention, or treatment), by type of methyl xanthine (eg, caffeine or theophylline) and by gestational age or birth wt. 
Family care  
 Family involvement In hospitalized preterm or LBW infants (P) do interventions to involve families in the infant’s routine health care (family involvement strategies, FIS) (I) compared with standard hospital or NICU care (C) improve critical outcomes (O) 
 Family support In preterm or LBW infants (P), do interventions to support the family to care for the infant in the home (I) compared with no or different interventions (C) improve critical outcomes (O) 
InterventionsPICO
Thermal care  
 Kangaroo mother care (KMC) In preterm or LBW infants (P), what is the effect of KMC (I) compared with conventional neonatal care (C) on critical outcomes (O)? If KMC is effective, then what is the effect of early‐onset KMC (I) compared with late‐onset KMC (C) on critical outcomes (O)? What is the effect of short (I) compared with longer (C) durations of KMC on critical outcomes (O)? 
Milk feeding  
 Mother’s own milk In preterm or LBW infants (P), what is the effect of feeding mother's own milk (I) compared with feeding infant formula (C) on critical outcomes (O)? 
 Donor human milk In preterm or LBW infants who cannot be fed mother's own milk (P), what is the effect of feeding donor human milk (I) compared with feeding infant formula (C) on critical outcomes (O)? 
 Infant formula In preterm or LBW infants who cannot be fed mother's own milk or donor human milk (P), what is the effect of feeding nutrient enriched (‘preterm’) infant formula (I) compared with feeding standard infant (“term”) formula (C) on critical outcomes (O)? 
 Fortification In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of multicomponent fortification of milk (I) compared with no fortification (C) on critical outcomes (O)? 
 Initiation of enteral feeding In preterm or LBW infants (P) what is the effect of early initiation of enteral feeding (I) compared with delayed feeding (C) on critical outcomes (O)? If early, then when should feeding be initiated? Does this effect differ in infants given full enteral feeding compared with infants given restricted volumes including minimal enteral feeding? 
 Responsive feeding In preterm or LBW infants who receive any enteral feeding (P), what is the effect of responsive feeding based on infants’ cues (I) compared with scheduled feeding (C) on critical outcomes (O)? 
 Volume advancement In preterm or LBW infants who receive any enteral feeding (P), what is the effect of fast advancement of enteral feeds (I) versus slower rates of feed advancement (C) on critical outcomes (O)? 
 Duration of exclusive breastfeeding In preterm or LBW infants (P), what is the effect of exclusive breastfeeding for less than 6 mo (I) compared with exclusive breastfeeding for 6 mo (C) on critical outcomes (O)? If less than 6 mo, then what is the optimal duration? 
Micronutrients  
 Iron In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral iron supplementation (I) compared with no iron supplementation (C) on critical outcomes (O)? 
 Zinc In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral zinc supplementation (I) compared with no zinc supplementation (C) on critical outcomes (O)? 
 Vitamin D In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral vitamin D supplementation (I) compared with no vitamin D supplementation (C) on critical outcomes (O)? 
 Vitamin A In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral vitamin A supplementation (I) compared with no vitamin A supplementation (C) on critical outcomes (O)? 
 Calcium and phosphorous In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral CaP04 supplementation (I) compared with no CaP04 supplementation (C) on critical outcomes (O)? 
 Multiple micronutrient supplements In preterm or LBW infants who are fed mother's own milk or donor human milk (P), what is the effect of enteral multiple micronutrient supplements (I) compared with no enteral multiple micronutrient supplements (C) on critical outcomes (O)? 
Probiotics  
 Probiotics In preterm or LBW infants who receive any enteral feeding (P), what is the effect of probiotics (I) versus no probiotics (C) on critical outcomes (O)? 
Skin care  
 Emolients In preterm or LBW infants (P) what is the effect of topical ointment, cream or oil applied to the skin (I) compared with routine skin care (C) on critical outcomes (O)? 
CPAP respiratory support  
 CPAP for respiratory distress In preterm infants with respiratory distress syndrome (P), what is the effect of any CPAP therapy (I) versus supportive care with oxygen therapy by head box, facemask, or nasal cannula (C) on critical outcomes (O)? 
 Early CPAP In preterm infants with respiratory distress syndrome (P), what is the effect of early CPAP (I) versus late CPAP(C) on critical outcomes (O)? 
 CPAP prophylaxis In preterm infants less than 32w regardless of respiratory status (P) What is the effect of CPAP started immediately after birth (I) compared with supportive care with oxygen therapy by head box, face mask, or nasal cannula (C) on critical outcomes (O)? -what is the effect of CPAP started immediately after birth (I) compared with mechanical ventilation (C) on critical outcomes (O)? 
 CPAP pressure source In preterm infants with respiratory distress syndrome, what is the effect of bubble (I) compared with other forms of CPAP (C) on critical outcomes (O)? 
Methyl xanthine respiratory management  
 Methyl xanthines In preterm infants, what is the effect of any methyl xanthine compared with no methyl xanthine on critical outcomes? What is the effect by indication (any, prevention, or treatment), by type of methyl xanthine (eg, caffeine or theophylline) and by gestational age or birth wt. 
Family care  
 Family involvement In hospitalized preterm or LBW infants (P) do interventions to involve families in the infant’s routine health care (family involvement strategies, FIS) (I) compared with standard hospital or NICU care (C) improve critical outcomes (O) 
 Family support In preterm or LBW infants (P), do interventions to support the family to care for the infant in the home (I) compared with no or different interventions (C) improve critical outcomes (O) 

PICO, population, intervention, comparator, outcome questions.

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