Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

Proportion of infants in control group meeting pre-defined safety criteria

Time frame: 7 days postnatal age

Reasons for non-recruitment

qualitative description of reasons for non-recruitment of eligible infants

Time frame: 7 days postnatal age

Reasons for non-adherence to protocol

qualitative description of reasons for non-adherence to protocol in randomized infants

Time frame: 7 days postnatal age

Completeness of data collection for clinical outcomes

Proportion of recruited infants with complete clinical outcome data

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

All-cause mortality during hospital stay

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Surgical/interventional PDA closure

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Receipt of any PDA pharmacotherapy

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Receipt of open-label rescue medical treatment in the control group

Time frame: 7 days postnatal age

Chronic lung disease

Oxygen or respiratory support requirement at 36 weeks' postmenstrual age or at discharge

Time frame: birth through 36 weeks post menstrual age

Postnatal corticosteroid use

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Pulmonary hemorrhage

blood-stained respiratory secretions with a significant increase in respiratory requirements (MAP\>12 and/or FiO2\>60%)

Time frame: 7 days postnatal age

Duration of invasive mechanical ventilation

Number of days on mechanical ventilation with an endotracheal tube

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Intraventricular hemorrhage

Grade I-IV according to Papile Criteria

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Severe intraventricular hemorrhage

Grade III-IV according to Papile Criteria

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Periventricular leukomalacia

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Necrotizing enterocolitis

Stage 2 or greater as per Bell's criteria

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Gastrointestinal bleeding

Time frame: within seven days of the first dose of pharmacotherapy

Gastrointestinal perforation

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Severe retinopathy of prematurity

stage 3 or greater

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Definite sepsis

Clinical symptoms and signs of sepsis and a positive bacterial culture in a specimen obtained from normally sterile fluids or tissue obtained at postmortem

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Oliguria

urine output less than 1 mL/kg/hour

Time frame: 7 days postnatal age

Duration of hospitalization (days)

Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)