Table 2

Primary and secondary outcome variables

Primary outcome
Primary outcome variablesNeurodevelopmental adverse events (ASD, ADHD, low IQ, communication and behavioural problems)
Atopic disorders
Reproductive disorders
Secondary outcomes
Secondary outcome variablesPharmacokinetic variables
Pharmacodynamic variables
Short-term outcomes

  • Increased hepatic transaminases.

  • Gastrointestinal haemorrhage.

  • Necrotising enterocolitis.

  • Feeding intolerance.

  • ADHD, attention deficit hyperactivity disorder; ASD, autism spectrum disorder.