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Table 5 Infant outcomes based on the Pediatric Trials Network

From: Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study

Adverse Event Serious Adverse Event
 Intestinal perforation
 NEC Bell stage II or III
 Perforation with intra-abdominal free air proceeding pneumatosis
 Fracture with immobilization only  Fracture requiring surgical intervention
 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)
 Seizure, no medical treatment Intraventricular hemorrhage (IVH) grade I or II  Seizure requiring medical treatment
 IVH grade III or IV
 PVL on imaging
 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
 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
 Hearing impairment  Confirmed hearing loss, unilateral or bilateral
 Pregnancy loss < 12 weeks, 0 days