Table 5 Infant outcomes based on the Pediatric Trials Network
Adverse Event | Serious Adverse Event |
|---|---|
Gastrointestinal | |
NEC Intestinal perforation | NEC Bell stage II or III Perforation with intra-abdominal free air proceeding pneumatosis |
Musculoskeletal | |
Fracture with immobilization only | Fracture requiring surgical intervention |
Pulmonary | |
Respiratory failure requiring oxygen Pneumothorax present but no treatment required Apnea, any Pulmonary hypertension, any | Respiratory failure requiring mechanical ventilation Pneumothorax requiring intervention (e.g. chest tube, nitric oxide, milrinone, sildenafil) |
Neurological | |
Seizure, no medical treatment Intraventricular hemorrhage (IVH) grade I or II | Seizure requiring medical treatment IVH grade III or IV PVL on imaging |
Cardiology | |
Hypotension, no pharmacologic treatment Electrocardiogram (EKG)QTc prolongation 460–485 ms Supraventricular tachycardia (SVT) resolving spontaneous or with noninvasive maneuvers (vagal maneuvers) | Hypotension requiring treatment with pressors EKG QTc prolongation > 485 ms SVT requiring medical treatment or cardioversion |
Infectious Disease | |
Wound infection requiring topical treatment only | Other infection proven by culture (urine, blood, sputum, cerebrospinal fluid) requiring antimicrobials |
Ophthalmologic | |
Conjunctivitis requiring local treatment Retinopathy or prematurity (ROP), any stage not requiring treatment | Conjunctivitis requiring systemic intervention or treatment ROP, Any stage requiring surgical or medical treatment |
Otolaryngology | |
Hearing impairment | Confirmed hearing loss, unilateral or bilateral |
Miscarriage | |
Pregnancy loss < 12 weeks, 0 days | |