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Active, Not Recruiting

NCT Number: NCT03978000

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
  • Birth weight 500-1500g
  • ≤ 48 hours of age
  • Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion criteria

  • Participation in any other interventional clinical trial
  • Infants in extremis to whom no further intensive care is offered by attending neonatologist
  • Infants with, or at a high probability for, early onset sepsis
  • Infants with recognized chromosomal anomalies
  • Congenital or acquired gastrointestinal disease
  • Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
  • Infants with known positive maternal HIV status

Treatment and study plan

IBP-9414

Drug

Oral suspension

Placebo

Drug

Sterile water

Primary outcomes

  1. Confirmed necrotizing enterocolitis (NEC)

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

  2. Time to sustained feeding tolerance

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Secondary outcomes

  1. At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication.

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

  2. Surgery (or autopsy) with confirmation of NEC

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

  3. Death all causes

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

  4. Number of days of hospitalization

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

  5. Weight gain in g/kg

    Time frame: Weeks 3 and 4 of age

  6. Number of subjects growing at ≥100 g/kg/week

    Time frame: Weeks 3 and 4 of age

  7. Days with clinical signs of feeding intolerance

    Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Sponsors and collaborators

Lead sponsor

Infant Bacterial Therapeutics

Industry

Registry information

Official study title

A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2019
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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