Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn

NCT01136577 | Terminated

• 1 other identifier: P070604
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Phototherapy is almost (beside exchange transfusion) the unique treatment for hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the light interacts with bilirubin at the skin level to transform it in water soluble products eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed at the skin level by the device (in the 430-490nm range) and on the exposed surface of the baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to LED, improving the amount of light energy emitted but on a smaller surface. The purpose of the study is to compare the efficacy of three ramps of phototherapy, one equipped with fluorescent tubes and two with LED (in a different technological settings) in the treatment of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.

Conditions

Hyperbilirubinemia

Keywords

Jaundice; Hyperbilirubinemia; Phototherapy; term newborn; LED; Fluorescent lamps

Outcome Measures

Primary Outcomes (1)

• Bilirubinemia

  24 hours

Secondary Outcomes (2)

• Evolution of bilirubinemia according to the device used

  6, 12,24, 48, 72 hours

• Hyperbilirubinemia rebound according to the device used

  24 and 48 hours after discontinuation

Study Arms (3)

LEDDYBLOO®

EXPERIMENTAL

LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs

Device: Phototherapy

Double BILITRON®

EXPERIMENTAL

Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS

Device: Phototherapy

Futura®

EXPERIMENTAL

Future phototherapy device equipped with 8 fluorescent tubes

Device: Phototherapy

Interventions

Phototherapy DEVICE

Phototherapy devices of ramp type placed over the incubator to treat with light in the 420-490nm range one face of the naked baby suffering jaundice.

Double BILITRON®; Futura®; LEDDYBLOO®

Eligibility Criteria

• Age: 35 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newborns in the hospital SAINT ANTOINE maternity wards
• Gestational age of 35w or more
• Healthy (no hypoxemia, no hypotonia, no abnormalities of thermic regulation, no infection or dehydration)
• No foeto-maternal incompatibility in rhesus or kell group
• With bilirubin level at 48h of 220µmoles/l or more if born at 38W or more or of 200µmoles/l or more if born between 35 and 38 W
• Parental information done and signed consent obtained
• Parents affiliated to social security

You may not qualify if:

• Conjugated bilirubin level at 25µmol/l or more
• Total bilirubin level over 300µmol/l indicating "intensive phototherapy"
• Severe haemolytic disease with anemia below 14g/land or hyperbilirubinemia before 48h of life), rhesus or kell incompatibility
• Parents who could not understand the information or sign the consent.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CNRHP, Saint Antoine Hospital

Paris, France, 75012, France

Location

Related Publications (25)

• American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.

  PMID: 15231951 BACKGROUND

• Bertini G, Dani C, Pezzati M, Rubaltelli FF. Prevention of bilirubin encephalopathy. Biol Neonate. 2001;79(3-4):219-23. doi: 10.1159/000047095.

  PMID: 11275655 BACKGROUND

• Bertini G, Perugi S, Elia S, Pratesi S, Dani C, Rubaltelli FF. Transepidermal water loss and cerebral hemodynamics in preterm infants: conventional versus LED phototherapy. Eur J Pediatr. 2008 Jan;167(1):37-42. doi: 10.1007/s00431-007-0421-3. Epub 2007 Feb 13.

  PMID: 17297614 BACKGROUND

• Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41. doi: 10.1542/peds.107.3.e41.

  PMID: 11230622 BACKGROUND

• Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14. doi: 10.1542/peds.103.1.6.

  PMID: 9917432 BACKGROUND

• Bhutani VK, Johnson L. Prevention of severe neonatal hyperbilirubinemia in healthy infants of 35 or more weeks of gestation: implementation of a systems-based approach. J Pediatr (Rio J). 2007 Jul-Aug;83(4):289-93. doi: 10.2223/JPED.1673. No abstract available.

  PMID: 17676232 BACKGROUND

• Bhutani VK, Maisels MJ, Stark AR, Buonocore G; Expert Committee for Severe Neonatal Hyperbilirubinemia; European Society for Pediatric Research; American Academy of Pediatrics. Management of jaundice and prevention of severe neonatal hyperbilirubinemia in infants >or=35 weeks gestation. Neonatology. 2008;94(1):63-7. doi: 10.1159/000113463. Epub 2008 Jan 17.

  PMID: 18204221 BACKGROUND

• Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. doi: 10.1016/j.pcl.2004.03.011.

  PMID: 15275978 BACKGROUND

• Chang YS, Hwang JH, Kwon HN, Choi CW, Ko SY, Park WS, Shin SM, Lee M. In vitro and in vivo efficacy of new blue light emitting diode phototherapy compared to conventional halogen quartz phototherapy for neonatal jaundice. J Korean Med Sci. 2005 Feb;20(1):61-4. doi: 10.3346/jkms.2005.20.1.61.

  PMID: 15716604 BACKGROUND

• Cohen SM. Jaundice in the full-term newborn. Pediatr Nurs. 2006 May-Jun;32(3):202-8.

  PMID: 16802676 BACKGROUND

• Grohmann K, Roser M, Rolinski B, Kadow I, Muller C, Goerlach-Graw A, Nauck M, Kuster H. Bilirubin measurement for neonates: comparison of 9 frequently used methods. Pediatrics. 2006 Apr;117(4):1174-83. doi: 10.1542/peds.2005-0590.

  PMID: 16585313 BACKGROUND

• Hansen TW. Acute management of extreme neonatal jaundice--the potential benefits of intensified phototherapy and interruption of enterohepatic bilirubin circulation. Acta Paediatr. 1997 Aug;86(8):843-6. doi: 10.1111/j.1651-2227.1997.tb08608.x.

  PMID: 9307164 BACKGROUND

• Lindgren C, Nilsson T. [Treatment of neonatal hyperbilirubinemia with BiliBed]. Tidsskr Nor Laegeforen. 1999 Nov 10;119(27):4027-9. Norwegian.

  PMID: 10613092 BACKGROUND

• Maisels MJ, Kring E. Transcutaneous bilirubin levels in the first 96 hours in a normal newborn population of > or = 35 weeks' gestation. Pediatrics. 2006 Apr;117(4):1169-73. doi: 10.1542/peds.2005-0744.

  PMID: 16585312 BACKGROUND

• Maisels MJ. What's in a name? Physiologic and pathologic jaundice: the conundrum of defining normal bilirubin levels in the newborn. Pediatrics. 2006 Aug;118(2):805-7. doi: 10.1542/peds.2006-0675. No abstract available.

  PMID: 16882840 BACKGROUND

• Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N Engl J Med. 2008 Feb 28;358(9):920-8. doi: 10.1056/NEJMct0708376. No abstract available.

  PMID: 18305267 BACKGROUND

• Maisels MJ, Newman TB. Surveillance of severe neonatal hyperbilirubinemia: a view from south of the border. CMAJ. 2006 Sep 12;175(6):599. doi: 10.1503/cmaj.060960. No abstract available.

  PMID: 16966662 BACKGROUND

• Newman TB, Liljestrand P, Jeremy RJ, Ferriero DM, Wu YW, Hudes ES, Escobar GJ; Jaundice and Infant Feeding Study Team. Outcomes among newborns with total serum bilirubin levels of 25 mg per deciliter or more. N Engl J Med. 2006 May 4;354(18):1889-900. doi: 10.1056/NEJMoa054244.

  PMID: 16672700 BACKGROUND

• Newman TB, Liljestrand P, Escobar GJ. Combining clinical risk factors with serum bilirubin levels to predict hyperbilirubinemia in newborns. Arch Pediatr Adolesc Med. 2005 Feb;159(2):113-9. doi: 10.1001/archpedi.159.2.113.

  PMID: 15699303 BACKGROUND

• Rubaltelli FF, Gourley GR, Loskamp N, Modi N, Roth-Kleiner M, Sender A, Vert P. Transcutaneous bilirubin measurement: a multicenter evaluation of a new device. Pediatrics. 2001 Jun;107(6):1264-71. doi: 10.1542/peds.107.6.1264.

  PMID: 11389241 BACKGROUND

• Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A new blue light-emitting phototherapy device: a prospective randomized controlled study. J Pediatr. 2000 Jun;136(6):771-4.

  PMID: 10839875 BACKGROUND

• Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A prospective randomized controlled study of phototherapy using blue and blue-green light-emitting devices, and conventional halogen-quartz phototherapy. J Perinatol. 2003 Mar;23(2):123-7. doi: 10.1038/sj.jp.7210862.

  PMID: 12673261 BACKGROUND

• Shapiro SM. Bilirubin toxicity in the developing nervous system. Pediatr Neurol. 2003 Nov;29(5):410-21. doi: 10.1016/j.pediatrneurol.2003.09.011.

  PMID: 14684236 BACKGROUND

• Smitherman H, Stark AR, Bhutani VK. Early recognition of neonatal hyperbilirubinemia and its emergent management. Semin Fetal Neonatal Med. 2006 Jun;11(3):214-24. doi: 10.1016/j.siny.2006.02.002.

  PMID: 16603425 BACKGROUND

• Stokowski LA. Fundamentals of phototherapy for neonatal jaundice. Adv Neonatal Care. 2006 Dec;6(6):303-12. doi: 10.1016/j.adnc.2006.08.004.

  PMID: 17208161 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia; Jaundice

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Anne Cortey, Doctor

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

FR (1)