Evaluation of the Implementation of Neonatal Phototherapy With BiliCocoon® in Maternity Wards (BiliCocoon)

Free bilirubin jaundice is a common condition in the neonatal period: 80% of newborns have some degree of hyperbilirubinemia within days of birth, but only 5-10% require treatment to prevent complications or to treat the cause of jaundice. The major complication is neurological toxicity, the most severe form of which is kernicterus, a severe and irreversible hyperbilirubinemic encephalopathy involving the basal ganglia. The main treatment for jaundice is phototherapy, which may or may not be combined with exchange transfusion in the most severe forms of jaundice caused by uncontrolled severe hemolysis. Phototherapy acts by interaction of light with bilirubin located in the skin, transforming it into photo-derivatives directly eliminated in the stool and urine. The hepatic stage of bilirubin transformation, limiting its elimination in newborns, is thus short-circuited. The interaction between bilirubin and light on the skin is maximal in the 460-490 nm spectrum. Phototherapy technology has evolved considerably since the discovery of its effectiveness by Dr. Cremer in 1958, with a constant progression in its effectiveness and indications. The light sources used in phototherapy devices are varied and today all use Light Emitting Diode (LED) technology. The models used today in phototherapy directly emit a blue wavelength, whose spectrum between 420 and 490 nm is the most effective. The effectiveness of the treatment also depends on the exposed skin surface, the homogeneity of the light intensity and the distance between the skin and the light source.

Other phototherapy equipment is also available, including the BiliCocoon® (Bilicocoon Bag, Eurocare®). This is a so-called "proximity" equipment. Thanks to the routing of the luminous flux by an optical fiber, the terminal light panel is put directly in contact with the baby's skin. This device allows an intensive and homogeneous radiation (35 µW/cm²/nm), and a wide coverage of the body surface (1200 cm²). The Bilicocoon® is a safe and controlled therapy that is performed in the mother's room, thus avoiding any separation, allows, during the treatment, to continue breastfeeding, is easy to install, does not require goggles and therefore no scope or hospitalization and thus reduces the workload of the nursing staff. A continuous treatment of 12 hours is required, interrupted only for the baby's change. Several sessions are sometimes necessary, and in case of failure, the child can be put under intensive phototherapy. The BiliCocoon® was implemented in our maternity hospital in August 2020 to avoid mother-child separations and to limit the number of hospitalizations in neonatology.

The objective of our study is to evaluate the impact on the number of hospitalizations in neonatology since its implementation, the failure rate (unchanged or increased bilirubinemia at the end of the Bilicocoon® session requiring a relai by intensive phototherapy) and the average length of stay of neonates treated for jaundice in the NDBS maternity unit of the GHPSJ. The secondary objectives are to evaluate the failure rate of Bilicocoon® : need for intensive phototherapy after a Bilicocoon® session (Bilicocoon® failure is defined by an unchanged or increased bilirubinemia at the end of the 12-hour session) and to evaluate the length of stay of children who had Bilicocoon® alone or intensive phototherapy alone for the same causes.

Study Overview

• Status: Completed
• Conditions: Neonatal Phototherapy

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newborn between 36 and 42 SA born between 01/08/2020 and 31/01/2022 at NDBS maternity and in postpartum care with their mother, treated with phototherapy

Description

Inclusion Criteria:

• Newborn between 36 and 42 SA born between 01/08/2020 and 31/01/2022 at NDBS maternity
• AND in postpartum care with their mother, treated with phototherapy
• French speaking parents

Exclusion Criteria:

• Parents objecting to participation in the study
• Parents deprived of liberty
• Parents under guardianship or curatorship
• Children initially hospitalized in neonatology from the time of birth, regardless of the cause.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospitalizations in neonatology for free bilirubin jaundice since the introduction of Bilicocoon	This outcome corresponds to the number of children hospitalized in neonatology for intensive phototherapy/number of children treated for jaundice.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate of Bilicocoon	This outcome corresponds to the number of children put under intensive phototherapy after BiliCocoon.	Month 1
Length of stay of children who received Bilicocoon alone or intensive phototherapy alone	This outcome corresponds to the average length of stay for children treated with intensive phototherapy alone or BiliCocoon alone for the same etiology.	Month 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

General Publications

• Luciano R, Mancini G, Cota F, Romano A, Purcaro V, Lerro F, Corsello M, Vento G. New high intensity fibreoptic phototherapy devices in healthy newborns: a single pad wrapped around the neonate body in comparison with a double pad device. Ital J Pediatr. 2019 Jun 6;45(1):68. doi: 10.1186/s13052-019-0663-5.
• Bhutani VK; Committee on Fetus and Newborn; American Academy of Pediatrics. Phototherapy to prevent severe neonatal hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2011 Oct;128(4):e1046-52. doi: 10.1542/peds.2011-1494. Epub 2011 Sep 26.
• Mills JF, Tudehope D. Fibreoptic phototherapy for neonatal jaundice. Cochrane Database Syst Rev. 2001;2001(1):CD002060. doi: 10.1002/14651858.CD002060.

Helpful Links

• Neonatal jaundice causes and management

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BiliCocoon

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No