Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy

NCT01904786 | Withdrawn Phase 1 DMC

• 1 other identifier: SLU22484
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two phases. The first occurs at the time of injury when brain cells in the affected area 'die'. There is nothing that can be done about this. The second phase of injury occurs over the next few days. This second phase is caused by inflammation and release of toxic chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has been shown to reduce the second phase of injury and bran death. All babies will receive the benefit of cooling. Although cooling helps it does not completely stop the second phase of injury. Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate the sleep-wake cycle. It has the potential to stop the second phase of brain injury by inhibiting inflammation and release of toxic chemicals. The reason for this research is to find out if melatonin can or cannot improve the outcome of babies with this kind of brain damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of six doses of medicine will be given. The baby's brain function will be assessed by an EEG, brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are routinely used as part of standard care for patients with this kind of problem. The only difference is that half the babies enrolled in the study will get the drug called melatonin and the other half will receive placebo. The dose of melatonin being used in the study is higher than the amount normally produced by the body. No side-effects of this dose have been reported in other research studies using melatonin in newborn and premature babies.

Conditions

Newborn Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic Ischemic Encephalopathy; Newborn; Outcomes; Melatonin

Outcome Measures

Primary Outcomes (1)

• Neurodevelopment at 18 months of life (BSID-III)

  The Bayley Scales of Infant Development III exam will be administered at 18 months of life to assess neurodevelopment.

  18 months

Secondary Outcomes (3)

• Seizure burden

  Assessed on day 3-4 of life

• Reduction in Burst Suppression

  Assessed on day 3-4 of life

• Improved cerebral oxygenation

  First 3-4 days of life

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin 40 mg every 8 hours for a total of six doses given over 48 hours orally (per nasogastric tube).

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo consists of the solvent solution without melatonin. Solvent solution consists of 5 mL of saline/alcohol mixture in a ratio of 90:1

Drug: placebo

Interventions

Melatonin DRUG

Melatonin

placebo DRUG

Placebo

Eligibility Criteria

• Age: 1 Hour - 8 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with moderate to severe hypoxic ischemic encephalopathy ≥36 weeks
• First dose of study drug given within 8 hours of birth

You may not qualify if:

• Major chromosomal or congenital defects

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Cardinal Glennnon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Farouk Sadiq, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: April 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2018
• Last Updated: July 3, 2015

Record last verified: 2015-01

Locations

US (1)