PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants

Launched by RIGSHOSPITALET, DENMARK · Feb 28, 2022

Keywords

ClinConnect Summary

The PrePhage trial is exploring a new way to help preterm infants, particularly those born very early, develop healthier guts and avoid a serious condition called necrotizing enterocolitis (NEC). NEC can be quite dangerous, affecting about 5-10% of preterm infants in neonatal intensive care units, with some children facing severe consequences. This study aims to see if transferring special viruses and proteins from healthy full-term infants to these preterm babies can improve their gut health and reduce the risk of NEC.

To participate in this trial, infants need to be born between 26 to 30 weeks of pregnancy and must be admitted to the neonatal intensive care unit shortly after birth. Parents will need to provide consent for their babies to join. The trial will first ensure the treatment is safe by testing it in preterm piglets before it’s given to infants. If the initial safety tests are successful, 20 preterm infants will be involved—half receiving the treatment and half receiving a placebo (a dummy treatment without the active ingredients). The researchers hope to find this treatment safe and effective, and if it shows promise, it could lead to larger studies in the future.

Gender

ALL

Eligibility criteria

• • Inclusion criteria for participant preterm infants
• • Preterm infants born between GA 26+0 and 30+6
• • Delivery at RH or transferred to RH NICU within 24 hours of delivery
• • Children administered prophylactic antibiotics due to maternal risk factors, specifically: premature rupture of membranes, groub b streptococcus positive, feber during labour
• • Signed parental consent
• • Exclusion criteria for participant preterm infants
• • Major congenital anomalies or birth defects
• • Antibiotics for more than 72 hours after birthExtremely SGA infant (weight SD score \< -3 SD)
• • Need for mechanical ventilation or cardiovascular support before first FFT treatment
• • Inclusion criteria for mothers of participants
• • Women aged 18-45
• • Ability to give informed consent
• • Exclusion criteria for participant mothers
• • ● Mothers who have severe infection, defined by need for other treatment to support infection-related comorbidities, besides from antibiotics (e.g. inotropic treatment, iv fluid resuscitation)