Regular Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants. A Randomized Controlled Trial Protocol

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity. Early feeding is a safe way to promote postnatal gastrointestinal maturation and, when compared with delayed enteral feeding, provide benefit, such as reduced time to full enteral feedings (TFF) and number of parenteral nutrition (PN) days. Failure to develop oral feeding competence often leads to growth failure, longer hospital stays, dependence on PN and its complications, and influences long-term growth and developmental outcomes. Feeding with human breast milk has a protective effect against necrotizing enterocolitis (NEC) compared with formula, whereas feeding intolerance is one of the early signs of NEC. Delayed passage of meconium is a risk factor for feeding intolerance in preterm very low birth weight neonates and specific meconium microbiota characteristics have been linked to increased risk of NEC. This randomized controlled trial (RCT) aims at evaluating the effect of regular intestinal lavage using normal saline on the TFF and severe complications such as NEC and sepsis, in extremely preterm infants. Investigators aim also to follow children´s neurological development until 5,5 years of age. The study will include one intervention group of 100 subjects that will receive regular rectal washout with normal saline and equal number of control subjects, treated according to current routine. The trial is preliminarily estimated to last between year 2018 and 2022. Investigators will monitor closely for possible adverse events. The results are going to be published in reviewed medical journal.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• born at Akademiska hospital in Uppsala

• gestational age between 22 weeks + 0 days and 26 weeks +6 days

• written informed consent obtained from both guardians before enrollment in the study.

Locations
Other Locations
Sweden
Neonatal intensiv care unit, 95F, Akademiska hospital
RECRUITING
Uppsala
Contact Information
Primary
Erik Normann, Chair
erik.normann@akademiska.se
+46186119628
Backup
Ulrica Ahlinder, Admin
ulrica.ahlinder@akademiska.se
+46186115606
Time Frame
Start Date: 2018-08-15
Estimated Completion Date: 2031-11
Participants
Target number of participants: 200
Treatments
Experimental: Intervention group
Regular intestinal lavage with normal saline twice per day, starting after randomization and not later than 24 hours of age, and continued until full enteral nutrition of 170ml/kg/day is achieved or NEC diagnosis (Bell stage II or more) is established, which one comes first. The intervention will be applied at a maximum of 2 weeks from birth.
No_intervention: Control group
Current routine for extremely preterm infants that do not defecate adequately will be applied.
Sponsors
Leads: Uppsala County Council, Sweden

This content was sourced from clinicaltrials.gov