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New treatment option for Hypoxic Ischemic Encephalopathy
Official title Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
ClinicalTrials.gov ID: NCT02621944
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, being studied as a potential treatment for hypoxic ischemic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6
You may be able to join if
- Eligible infants are \>36 0/7th weeks gestation,
- pH (cord or neonatal) \<7.0,
- base deficit \>16 mEq/L,
- no available blood gas,
- a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
You likely can't join if
- suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
- clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
- a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.
See the full eligibility criteria
- Eligible infants are \>36 0/7th weeks gestation,
- pH (cord or neonatal) \<7.0,
- base deficit \>16 mEq/L,
- no available blood gas,
- a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
- base deficit between 10 and 15.9 mEq/L,
- infants must have a history of an acute perinatal event,
- either a 10-minute Apgar \< 5 or a continued need for ventilation,
- All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
- neonates cooled within 6 hours of birth will be included in the study.
- suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
- clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
- a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.