Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice

NCT03570775 | Completed DMC

• 1 other identifier: 2015/186
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a sleeping bag), comparing it with conventional hospital phototherapy. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight hospitalized requiring phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Bilirubin levels were taken at the start of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, 120 min and every 24 hours during intervention. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of means was made for the decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.

Conditions

Phototherapy; Jaundice, Neonatal

Keywords

hyperbilirubinemia; treatment; devices; newborn; phototherapy

Outcome Measures

Primary Outcomes (1)

• Bilirubin reduction rate in mg/dl/h

  Bilirubin lowering rate (initial seric bilirubin- final seric bilirubin/time of phototherapy)

  through study completion, an average of 5 days

Secondary Outcomes (9)

• Patient temperature during phototherapy

  through study completion, an average of 5 days

• Incidence of skin lesions related to phototherapy

  through study completion, an average of 5 days

• Incidence of dehydration related to phototherapy

  through study completion, an average of 5 days

• Incidence of diarrhea related to phototherapy

  through study completion, an average of 5 days

• Incidence of other side effects related to phototherapy

  through study completion, an average of 5 days

Study Arms (2)

"Neomedlight" Sleeping bag phototherapy

EXPERIMENTAL

Phototherapy device with LED light + fiber optic mesh

Device: Sleeping bag phototherapy

Conventional phototherapy

ACTIVE COMPARATOR

LU-6T model: phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated.

Device: Conventional phototherapy

Interventions

Sleeping bag phototherapy DEVICE

This device has a LED light emitter that incorporates one fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. The phototherapy sleeping bag is conceived with the aim of increasing the surface of phototherapy by means of a double exposure: ventral and dorsal, which allows the insertion of two phototherapy devices of 20x30 centimeters. The ventral and dorsal caps incorporate mesh optical fibers that are connected to the light emitter, in which the phototherapy time can be programmed. The fiber optic meshes are protected by a vinyl cover and a disposable lining for patient comfort and hygiene.

Also known as: "Neomedlight" sleeping bag phototherapy device

"Neomedlight" Sleeping bag phototherapy

Conventional phototherapy DEVICE

This is a phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. The device has a minimum height of 106 cm and a maximum of 152 cm, a depth of 64 cm and a width of 72 cm. The manufacturer recommends not using the lamp at distances of less than 50 cm because, although the heat radiation is minimal, this can influence distances less than 50 cm when the child is also exposed to infrared thermal radiation, typical of the servo cribs It is recommended to control temperature and eye protection due to the risk of ophthalmic injury from light, since the intensity of the light is concentrated in a single point.

Also known as: LU-6T phototherapy

Conventional phototherapy

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and management recommendations for preterm infants under 35 weeks, adopted by the newborn unit of San Ignacio University Hospital.
• Birth weight more than 2000 grams.
• Parents are required to sign informed consent where they agree to participate in the study

You may not qualify if:

• Diagnosis of pemphigus, scalded skin or burns that make phototherapy difficult.
• Patient who requires transfer for management in another institution by their health insurer.

Sponsors & Collaborators

• Nathalie Charpak: lead
• Hospital Universitario San Ignacio: collaborator
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, 110231, Colombia

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margarita Andrade, Dr.

  Hospital Universitario San Ignacio

  STUDY CHAIR

• Nathalie Charpak, Dr.

  Kangaroo Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Randomized controlled clinical trial with newborns over 2000 grams of birth weight and diagnosis of indirect hyperbilirubinemia, requiring phototherapy. Patients were randomized to phototherapy with the LED sleeping bag or conventional phototherapy with blue light panels.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 27, 2018
• Study Start: March 1, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 5, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)