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Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)

NCT03897101 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-03-25

No results posted yet for this study

Summary

Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births. Over the last six years, several randomized control trials have demonstrated that therapeutic hypothermia reduces the rate of death or disability at 18 months of age among infants who survived. However, the neurodevelopmental outcome in milder NE not treated with hypothermia remains unclear.

A multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .

Conditions

  • Neonatal Encephalopathy
  • Cell Damage
  • Metabolic Acidosis
  • Inflammation

Sponsors & Collaborators

  • AUSL Romagna Rimini

    collaborator OTHER

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Anna Tarocco, MD · University Hospital s. Anna Ferrara

Eligibility

Min Age
15 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897101 on ClinicalTrials.gov