Status:
UNKNOWN
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
Lead Sponsor:
University Hospital of Ferrara
Collaborating Sponsors:
AUSL Romagna Rimini
Conditions:
Hypoxic-Ischemic Encephalopathy
Cell Damage
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. The ...
Detailed Description
It is a randomized double blind, placebo controlled trial on 100 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whol...
Eligibility Criteria
Inclusion
- gestational age \> 35 weeks and weight \> 1800 gr
- Apgar score \< 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess \> 12 mmol/L or pH \< 7,0 at initial blood gas analyses
- evidence of moderate or severa encephalopathy graded according to Sarnat\&Sarnat neurological evaluation
- abnormal amplitude integrated electroencephalography
Exclusion
- suspected inborn errors of metabolism
- major chromosomal congenital defects
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03806816
Start Date
December 13 2018
End Date
December 31 2022
Last Update
October 11 2019
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Pediatrico Bambin Gesù
Vatican City, Holy See
2
ospdale di Bolzano
Bolzano, Italy
3
Bufalini Hospital Cesena
Cesena, Italy
4
University Hospital "Sant'Anna" of Ferrara
Ferrara, Italy, 44124