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Melatonin for Neonatal Hypoxic-Ischemic Encephalopathy
Phase < 1
Recruiting
Led By Michael D Weiss, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Either a 10-minute Apgar < 5 or a continued need for ventilation
Eligible infants are >36 0/7th weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 - 20 months
Awards & highlights
Study Summary
This trial will test whether melatonin, a naturally occurring substance, can help improve outcomes for infants with HIE when used in addition to the standard therapy of induced systemic hypothermia.
Who is the study for?
This trial is for newborns over 36 weeks gestation with Hypoxic-Ischemic Encephalopathy (HIE). They must have had an acute event at birth, show signs of brain dysfunction early on, and meet specific blood criteria. Infants already receiving cooling therapy within 6 hours of birth are eligible. Those with suspected meningitis, metabolic disorders, severe hypoglycemia, or significant congenital issues cannot participate.Check my eligibility
What is being tested?
The study tests melatonin's ability to protect the brain in combination with induced hypothermia in infants suffering from HIE. It aims to find the right dose of melatonin that could help minimize brain cell death by acting as a free radical scavenger and reducing inflammation.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include sleepiness due to melatonin's role in regulating sleep cycles. Other possible reactions might be minor digestive disturbances or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn had a low Apgar score or needed help breathing after birth.
Select...
My baby was born after 36 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 18 - 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 - 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bayley-III Index Scores (Cognitive, Language, and Motor) will be used for neurological outcome assessment
Number of participants with treatment-related adverse events as assessed by MedDRA ??? This is something the PI/Team needs to agree on which one to use.
Peak Plasma Concentration (Cmax) of Melatonin 0.5 mg/kg.
+3 moreSecondary outcome measures
Bayley-III Index Scores Subscales (Receptive and Expressive Language, Fine and Gross Motor) will be used for neurological outcome assessment
Evaluation of The Impact of Melatonin using Magnetic Resonance Image (MRI)
Side effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Group I: Participants 21-30Experimental Treatment4 Interventions
This group will receive Melatonin dose of 5 mg/kg enterally, only if the group Participants 11-20 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.
The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.
Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Group II: Participants 11-20Experimental Treatment4 Interventions
This group will the Melatonin dose of 3 mg/kg enteral, only if the group Participants 1-10 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.
The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.
Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Group III: Participants 1-10Experimental Treatment4 Interventions
This group will receive a 0.5 mg/kg enteral dose of Melatonin. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life.
The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns.
Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,576 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,304 Total Patients Enrolled
Michael D Weiss, MDPrincipal InvestigatorUniversity of Florida
3 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The pH level in the cord or newborn baby's blood is less than 7.0.I was born with abdominal issues and other birth defects or genetic conditions.My newborn had a low Apgar score or needed help breathing after birth.My newborn was cooled within 6 hours of birth.I show signs of meningitis during a sepsis check.No blood gas test results are available.I have high ammonia levels and low blood sugar.My baby was born after 36 weeks of pregnancy.Your base deficit level is between 10 and 15.9 mEq/L.The baby's blood test within the first hour after birth shows a pH level between 7.0 and 7.15.My infant showed signs of brain distress within 6 hours of birth.Babies must have experienced a serious event around the time of birth.Your base deficit is more than 16 mEq/L.
Research Study Groups:
This trial has the following groups:- Group 1: Participants 11-20
- Group 2: Participants 21-30
- Group 3: Participants 1-10
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What role does Melatonin play in human physiology, and has this been looked at before?
"There are currently 25 Melatonin trials underway, 4 of which have reached Phase 3. The majority of these clinical trials originate out of Houston, Texas; however, there are 26 total locations running these tests."
Answered by AI
Are there any positions available for participants in this clinical trial?
"According to the latest information available on clinicaltrials.gov, this study is still looking for patients to enroll. The first posting was on November 1st, 2016, with the most recent edit happening on May 23rd, 2022."
Answered by AI
Has this clinical trial been conducted before?
"There are currently 25 live studies for Melatonin across 13 cities and 9 countries. The initial clinical trial for Melatonin occurred in 2007. The trial, sponsored by Eli Lilly and Company, involved 20 participants and completed its N/A drug approval stage. Since 2007 years, 203 trials have been completed."
Answered by AI
How many people total will be participating in this clinical trial?
"The listed clinical trial on clinicaltrials.gov is presently looking for patients to enroll. The details of the study were first posted on November 1st, 2016 and have been edited as recently as May 23rd, 2022. This particular research project is recruiting 70 individuals from 2 locations."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
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