Light/Dark Cycle Promotes Weight Gain in Preterm Infants

NCT05230706 | Completed

• 1 other identifier: FOSISS-272596
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Circadian rhythms; Chronotherapy; Melatonin; Neonatology; Weight gain

Outcome Measures

Primary Outcomes (1)

• Weight gain

  Was determined by daily weighting (08:00-09:00 hours of every morning) using a pediatric precision scale, the result was subtracted from the previous day registered weight in order to obtain the total daily weight gain.

  The body weight gain during the initial 29 days of hospitalization

Secondary Outcomes (2)

• Early hospital discharge

  through study completion, an average of 8 weeks

• Salivary melatonin levels

  The first 20 days of NICU stay

Study Arms (2)

Control (CBL)

NO INTERVENTION

The control group was kept under normal room light conditions (CBL) 24 hours a day (level of illumination was 275.82±14 lux during the day and 145.28±14 lux at night).

Experimental (LDC)

EXPERIMENTAL

The experimental group were allocated to alternating light/darkness conditions as follows: from 07:00 to 19:00 hours the subjects were kept under normal room light conditions; from 19:00 to 07:00 of the following day the conditions were modified by placing the patient under an acrylic cephalic helmet (length: 27 cm; width: 27 cm; height: 17.5 cm; opening: 17x12 cm). The helmet was covered with surgical cloth (green or blue) folded to 50x60cm rectangles, leaving the frontal part open in order to maintain an adequate air flow. This intervention exposed infants in the experimental group to light at 25 lux for 12 hours every day, while during daytime the cloth was removed in order for study subjects to be exposed to regular room lighting.

Other: Cephalic helmet

Interventions

Cephalic helmet OTHER

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.

Experimental (LDC)

Eligibility Criteria

• Age: 1 Week - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Eligible patients were premature infants (gestational age \<37 weeks) who were hospitalized in the low risk and high-risk neonatal units of participating institution, with a non-severe diagnosis for hospitalization, without concomitant illness, and classified as stable.
• The parents or legal guardians of all included patients provided written informed consent to participate in this study.

You may not qualify if:

• Elimination criteria included infants initially classified as having a non-severe illness who progress to severe illness, infants who received intensive treatment for over a week due to medical complications (i.e. bacterial infections), as well as infants whose parents requested withdrawal from participating in the study.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• National Council of Science and Technology, Mexico: collaborator
• Universidad Autónoma Benito Juárez de Oaxaca: collaborator
• Hospital General Dr. Aurelio Valdivieso: collaborator
• Centro Medico Nacional La Raza, IMSS: collaborator
• Hospital General Regional No. 1 IMSS: collaborator

Related Publications (5)

• Escobar C, Rojas-Granados A, Angeles-Castellanos M. Development of the circadian system and relevance of periodic signals for neonatal development. Handb Clin Neurol. 2021;179:249-258. doi: 10.1016/B978-0-12-819975-6.00015-7.

  PMID: 34225966 BACKGROUND

• Vasquez-Ruiz S, Maya-Barrios JA, Torres-Narvaez P, Vega-Martinez BR, Rojas-Granados A, Escobar C, Angeles-Castellanos M. A light/dark cycle in the NICU accelerates body weight gain and shortens time to discharge in preterm infants. Early Hum Dev. 2014 Sep;90(9):535-40. doi: 10.1016/j.earlhumdev.2014.04.015. Epub 2014 May 13.

  PMID: 24831970 BACKGROUND

• Rivkees SA. Developing circadian rhythmicity. Basic and clinical aspects. Pediatr Clin North Am. 1997 Apr;44(2):467-87. doi: 10.1016/s0031-3955(05)70486-7.

  PMID: 9130930 BACKGROUND

• Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.

  PMID: 39699174 DERIVED

• Sanchez-Sanchez M, Garcia TL, Heredia D, Resendiz I, Cruz L, Santiago J, Rojas-Granados A, Ubaldo-Reyes L, Perez-Campos-Mayoral L, Perez-Campos E, Vasquez GS, Moguel JM, Zarate R, Garcia O, Sanchez L, Torres F, Paz A, Elizarraras-Rivas J, Hernandez-Huerta MT, Angeles-Castellanos M. Effect of a light-darkness cycle on the body weight gain of preterm infants admitted to the neonatal intensive care unit. Sci Rep. 2022 Oct 20;12(1):17569. doi: 10.1038/s41598-022-22533-1.

  PMID: 36266474 DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Manuel Angeles Castellanos

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects randomized to the experimental group were allocated to alternating light/darkness conditions as follows: from 07:00 to 19:00 hours the subjects were kept under normal room light conditions; from 19:00 to 07:00 of the following day the conditions were modified by placing the patient under an acrylic cephalic helmet which exposed them to light at 25 lux for 12 hours every day. The control group was kept under normal room light conditions (CBL) 24 hours a day.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 9, 2022
• Study Start: September 10, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: As of 6 months after publication
• Access Criteria: All the IPD of the results can be requested directly from the person in charge of the study, complying with the established time