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Completed

NCT Number: NCT02472769

IBP-9414 for the Prevention of Necrotizing Enterocolitis

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

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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 2

Primary location

Univ. Arkansas Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age ≤32 weeks
  • Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
  • < 48 hours of age.
  • Written informed consent from the patient's legally authorized representative(s).

Exclusion criteria

  • Participation in an additional interventional clinical trial in which an investigational drug will be administered.
  • Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
  • Congenital or acquired gastrointestinal pathology.
  • Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.

Treatment and study plan

IBP-9414

Drug

Placebo

Drug

Sterile water

Primary outcomes

  1. Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Infant Bacterial Therapeutics

Industry

Registry information

Official study title

A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2015
Registry last updated
Dec 29, 2017

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

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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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