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Table 3 Forty-eight-hour adverse events

From: Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial

Adverse event

Definition

Apnea

Cessation of breathing for more than 20 s, or a shorter pause accompanied by bradycardia (< 100 beats per minute) and/or oxygen desaturation [19]

Increased gastric residuals

An aspirated amount of > 2 ml/Kg or > 50% of the previous feeding volume from the stomach, following administration of enteral feeding, as evaluated in preterm infants who are being fed via an orogastric or nasogastric tube [20, 21]

Inhibited duodenal motor activity

Lower duodenal motility during fasting [22]

Delayed gastric emptying

Large gastric residual volumes associated with enteral feeding as a result of gastroparesis or delayed gastric emptying [21]

Feeding intolerance

Inability to digest enteral feedings, associated with increased gastric residuals, abdominal distension, and/or emesis [23]. If the combination of the above phenomena is observed, this will constitute diagnosis of feeding intolerance; otherwise these phenomena will be annotated individually

Abdominal distension

An actual increase in abdominal size and measurable change (≥ 2 cm) in abdominal girth [24]

Vomiting

At least one episode of uncomfortable, involuntary, forceful throwing up of gastric content, as distinguished from spitting up that occurs because of rapid infant feeding, air swallowing, or overfeeding

Paralytic ileus

Impaired motor activity of the bowel without the presence of a physical obstruction

Acute gastric dilatation

Distension of abdomen with constant nasogastric aspirate and/or absence of gas in distal bowel along with the presence of dilated stomach radiographically, which is frequently associated with feeding intolerance or sometimes is associated with a surgical condition, e.g., necrotizing enterocolitis or bowel obstruction [21, 25].

Necrotizing enterocolitis

Bell’s stage ≥ II [26]