Status:
COMPLETED
Earing Protectors Influence on Newborns Preterm Sleep Pattern
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Sleep
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief Summary
Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effe...
Eligibility Criteria
Inclusion
- Preterm Newborns inside the incubator;
- Preterm Newborns clinically stable;
- Preterm Newborns with no change in hearing screening test;
- Preterm Newborns current weight between 1200 and 2000g.
Exclusion
- Preterm Newborns in phototherapy;
- Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
- Preterm Newborns with any type of congenital malformation;
- Preterm Newborns with periventricular hemorrhage grades II, III and IV;
- Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;
- Preterm Newborns using corticoids;
- Preterm Newborn whose mother has a history of illicit drug use during pregnancy
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03373578
Start Date
October 1 2012
End Date
February 1 2016
Last Update
December 14 2017
Active Locations (1)
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1
Federal Uiversity of São Paulo
São Paulo, Brazil, 04024-002