CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Cephalic helmetother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05230706
NCT05230706N/ACompleted

Application of a Light/Dark Cycle in Preterm Neonates and Its Association With Shorter In-hospital Stay

Universidad Nacional Autonoma de Mexico·interventional·Posted Feb 9, 2022·Updated Dec 13, 2022

In Brief

A clinical study evaluating Cephalic helmet for Preterm Infants. Completed, enrolled 300 participants.

Detailed Summary

The study focuses on the use of light/dark alternation as chronotherapy to prevent deterioration and reduce morbidity and mortality in premature patients, as well as favoring circadian alteration after birth, which should lead premature infants to a better evolution in life. NICU. With the hypothesis that exposure to light/dark cycles during hospitalization of preterm infants will decrease hospital stay. In addition, the light/dark cycle will allow a circadian organization of physiological variables such as salivary levels of cortisol and melatonin. To identify the benefits of the light/dark cycle in the clinical maturation of preterm newborn patients and early hospital discharge in preterm newborns.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2022
Enrollment StartSep 10, 2016
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 4.4 years ago

Interventions

Cephalic helmetother

An acrylic headgear (length: 27 cm; width: 27 cm; height: 17.5 cm; opening: 17x12 cm) was placed on the patient's head. The helmet was covered with surgical cloth (green or blue) folded into 50x60cm rectangles, leaving the front part open to maintain adequate airflow.