Using intestinal lavage to improve feeding and prevent NEC in very preterm infants
Regular Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants. A Randomized Controlled Trial Protocol
This study is testing if washing out the intestines with saline can help very preterm babies eat better and reduce the risk of a serious gut condition called NEC.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 22 Weeks to 26 Weeks |
| Sex | All |
| Sponsor | Uppsala County Council, Sweden Government |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT03631979 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to optimize enteral nutrition in extremely preterm infants by comparing the effects of intestinal lavage with normal saline against standard feeding practices. The study will be conducted as a two-arm parallel, open-label, randomized controlled trial at a tertiary-care hospital, with infants randomly assigned to either the intervention or control group shortly after birth. The primary focus is on reducing the incidence of necrotizing enterocolitis (NEC) and improving the time to full enteral nutrition. The trial will include approximately 200 participants over a recruitment period of up to five years.
Who should consider this trial
Good fit: Ideal candidates for this study are extremely preterm infants born at Akademiska hospital with a gestational age between 22 weeks + 0 days and 26 weeks + 6 days.
Not a fit: Patients with major congenital anomalies or circulatory instability during the first hours of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of NEC and improve feeding outcomes in extremely preterm infants.
How similar studies have performed: While similar approaches have been explored, this specific intervention of intestinal lavage in this population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * major dysmorphic features consistent with chromosomal abnormality * major congenital anomalies, such as gastrointestinal disorders * circulatory instability during the first hours of life
Where this trial is running
Uppsala
- Neonatal intensiv care unit, 95F, Akademiska hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Spyridon Gialamas, MD, PhD — Neonatal Intensive Care Unit, Akademiska Hospital
- Study coordinator: Erik Normann, Chair
- Email: erik.normann@akademiska.se
- Phone: +46186119628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.