Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants

NCT03631979 | Terminated DMC

• 1 other identifier: 2018/141
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necrotizing Enterocolitis; Time to Full Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Time to full enteral nutrition (FEN)

  The time period between birth and achievement of enteral nutrition of 170ml/kg/d (days)

  From birth until full term corrected age (gestational age 40 weeks + 0 days)

Secondary Outcomes (21)

• Necrotizing enterocolitis (NEC)

  From birth until full term corrected age (gestational age 40 weeks + 0 days)

• Neonatal sepsis

  From birth until full term corrected age (gestational age 40 weeks + 0 days)

• Incidence of Retinopathy of Prematurity (ROP)

  From birth until full term corrected age (gestational age 40 weeks + 0 days)

• Grade of ROP

  From birth until full term corrected age (gestational age 40 weeks + 0 days)

• Bronchopulmonary dysplasia (BPD)

  From birth until 36 weeks postnatal age or discharge, whichever comes first

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Intestinal lavage with normal saline

Control group

NO INTERVENTION

Current routine for extremely preterm infants that do not defecate adequately will be applied.

Interventions

Intestinal lavage with normal saline OTHER

Specially trained pediatric surgeon will administer 10ml/kg pre-warmed (37oC) normal saline via a single-use rectal tube of size 6FR twice per day, aiming at a depth of maximum 10 cm/kg, 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. However, the intervention will be applied at a maximum of 2 weeks from birth.

Intervention group

Eligibility Criteria

• Age: 22 Weeks - 26 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• major dysmorphic features consistent with chromosomal abnormality
• major congenital anomalies, such as gastrointestinal disorders
• circulatory instability during the first hours of life

Sponsors & Collaborators

• Uppsala County Council, Sweden: lead

Study Sites (1)

Neonatal intensiv care unit, 95F, Akademiska hospital

Uppsala, 75185, Sweden

Location

Related Publications (26)

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• Ibrahim T, Li Wei C, Bautista D, Sriram B, Xiangzhen Fay L, Rajadurai VS. Saline Enemas versus Glycerin Suppositories to Promote Enteral Feeding in Premature Infants: A Pilot Randomized Controlled Trial. Neonatology. 2017;112(4):347-353. doi: 10.1159/000477999. Epub 2017 Aug 3.

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• Shinde S, Kabra NS, Sharma SR, Avasthi BS, Ahmed J. Glycerin suppository for promoting feeding tolerance in preterm very low birthweight neonates: a randomized controlled trial. Indian Pediatr. 2014 May;51(5):367-70. doi: 10.1007/s13312-014-0418-8.

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MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Erik Normann, Chair

  Neonatal Intensive Care Unit, Akademiska Hospital

  STUDY CHAIR

• Spyridon Gialamas, MD, PhD

  Neonatal Intensive Care Unit, Akademiska Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 15, 2018
• Study Start: August 15, 2018
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)