Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?

Necrotising enterocolitis (NNAP definition)

NEC diagnosed at postmortem or NEC diagnosed during surgery or NEC diagnosed using clinical and radiographic features (where the infant has at least one clinical feature (bilious gastric aspirate or emesis, abdominal distension, occult, gross blood in stool) and at least one radiographic feature (pneumatosis, hepato-biliary gas, pneumoperitoneum)).

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Pragmatically defined NEC

Infants who had a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Late onset sepsis

HQIP NNAP case definition

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Pragmatically defined late onset sepsis

Growth of any organisms that appear in the NNAP lists of "Clearly pathogenic organisms" and "Other organisms"

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Survival to discharge home

Time frame: On date of discharge from final neonatal unit, assessed up to 24 months

Survival without severe NEC or late onset sepsis (LOS)

LOS is defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition i.e. blood stream or cerebrospinal fluid confirmed pure growth in culture after first three days of life

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Survival without any NEC

NEC is defined as per the NNAP definition

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Brain injury

Either left or right grade 3 or higher intra-ventricular haemorrhage or cystic periventricular leukomalacia

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Treated retinopathy of prematurity

Defined as cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Stage of retinopathy of prematurity

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Bronchopulmonary dysplasia

Defined as any respiratory or ventilatory support or supplemental oxygen at 36 weeks postmenstrual age

Time frame: 36 weeks postmenstrual age

Severe bronchopulmonary dysplasia

Defined as ventilation via endotracheal tube or trachestomy, and excluding non-invasive support or CPAP, at 36 weeks postmenstrual age

Time frame: 36 weeks postmenstrual age

Length of stay

Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants

Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months

Time to full feeds

Defined as the number of days until an infant is recorded as not requiring any parenteral nutrition or fluid (i.e. no parenteral nutrition or intravenous dextrose)

Time frame: Before discharge from final neonatal unit

Growth

Weight for post-menstrual age standard deviation score

Time frame: 36 weeks corrected gestational age