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 | |