Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice

NCT03569254 | Completed DMC

• 1 other identifier: 2015/187
• Study Type: interventional
• Target: 64
• 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 blanket), comparing it with the Ohmeda BiliBlanket Plus®. Methods: randomized controlled clinical trial with preterm or low birth weight infants 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 64 patients was calculated(5% losses), 32 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. Seric bilirubin levels were taken at the start and at the end of phototherapy. Controls were done every 2 hours with the Bilicheck spectrophotometer device. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, and every 2 hours during intervention. Physical examination and recording of side effects related 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

Jaundice, Neonatal; Phototherapy

Keywords

infant, newborn; devices; treatment; hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Bilirubin change rate in mg/dl/h

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

  through study completion, an average of 6 hours

Secondary Outcomes (9)

• Patient temperature during phototherapy

  through study completion, an average of 6 hours

• Incidence of skin lesions related to phototherapy

  through study completion, an average of 6 hours

• Incidence of dehydration related to phototherapy

  through study completion, an average of 6 hours

• Incidence of diarrhea related to phototherapy

  through study completion, an average of 6 hours

• Incidence of other side effects related to phototherapy

  through study completion, an average of 6 hours

Study Arms (2)

Neomedlight Phototherapy Blanket

EXPERIMENTAL

Phototherapy with a fiber-optic device based on LED light administered intermittently for a total of 6 hours with periods of 2 hours in kangaroo position and pauses of 1 hour at the end of each period.

Device: Neomedlight Phototherapy Blanket

Ohmeda-Fiber Optic Phototherapy Blanket

ACTIVE COMPARATOR

Phototherapy with a fiber-optic device: the Ohmeda fiber optic Phototherapy blanket

Device: Ohmeda-Fiber Optic Phototherapy Blanket

Interventions

Neomedlight Phototherapy Blanket DEVICE

The NeoMedLight® phototherapy blanket is an innovative new fiber-optic device based on LED light. Its light emitting surface area is 40.5x30 cm or 1200 cm2. The device size is 40.5 x30 cm. It incorporates fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. This device provides therapeutic light (404-515nm) to a wide extension of the body surface area. Its average irradiation footprint is 35uW / cm2 / nm ± 15%. The phototherapy was done intermittently in periods of 2 hours with 1 hour of rest for a total time of 6 hours in kangaroo position.

Neomedlight Phototherapy Blanket

Ohmeda-Fiber Optic Phototherapy Blanket DEVICE

This device is a high performance version of Ohmeda Medical's Biliblanket that uses a fiber optic cable to deliver light from a high-intensity lamp to a device composed of a fiber optic fabric. The device has a disposable liner and is left in direct contact with the patient. The patient is exposed to a light with a wavelength between 400 and 550 nanometers. The phototherapy system consists of a light emitting unit, a fiber optic cable four feet long (121.9 cm) and a lightweight mattress. It has two available sizes: 4.38 x 9.38 inches (11.12 x 23.83 cm) and 4.00 x 6.00 inches (10.16 x 15.2 cm).

Ohmeda-Fiber Optic Phototherapy Blanket

Eligibility Criteria

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

You may qualify if:

• Low Risk Hyperbilirubinemia requiring phototherapy according to the guidelines of the American Academy of Pediatrics and recommendations for management of premature infants under 35 weeks, adopted by the Kangaroo Mother Care Ambulatory Program.
• Start of jaundice at a chronological age greater than 48 hours.
• Bilirubin level ≤18 mg / dL
• Knowledge of blood groups of mother and child.
• Parents are required to sign informed consent where they agree to participate in the study.

You may not qualify if:

• Parents without availability to stay in the Kangaroo Mother Care Program for at least 6 hours.
• Extensive skin lesions due to burns or sloughing at the physical examination prior to entering the study.

Sponsors & Collaborators

• Nathalie Charpak: lead
• Hospital Universitario San Ignacio: 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

• Nathalie Charpak, Dr.

  Kangaroo Foundation Director

  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: Parallel assignment randomized controlled clinical trial with preterm or low birth weight infants who have low risk hyperbilirubinemia requiring phototherapy

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 26, 2018
• Study Start: March 1, 2016
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)