Light/Dark Cycle Promotes Weight Gain in Preterm Infants

NCT05230706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-12-13

No results posted yet for this study

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.

Conditions

  • Preterm Infants

Interventions

OTHER

Cephalic helmet

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.

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER
  • Universidad Autónoma Benito Juárez de Oaxaca

    collaborator OTHER
  • Hospital General Dr. Aurelio Valdivieso

    collaborator OTHER
  • Centro Medico Nacional La Raza, IMSS

    collaborator OTHER
  • Hospital General Regional No. 1 IMSS

    collaborator OTHER_GOV
  • Universidad Nacional Autonoma de Mexico

    lead OTHER

Principal Investigators

  • Alberto Manuel Angeles Castellanos · Universidad Nacional Autonoma de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-10
Primary Completion
2020-01-31
Completion
2020-01-31

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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 NCT05230706 on ClinicalTrials.gov