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

Hyperbilirubinemia Clinical Trial

— DELF  

Official title:

Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01136577
• Other study ID #: P070604
• Status: Terminated
• Phase: N/A
• First received: June 2, 2010
• Last updated: December 10, 2012
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Description:

Term and healthy newborns on maternity wards in SAINT-ANTOINE hospital are checked everyday for jaundice with bilirubinometer JM-103®. If indicated (nomogram included in patient charts), a plasmatic bilirubin level is performed. If the baby is two days old or more with a bilirubin level indicating standard phototherapy (by opposition to intensive phototherapy), the parents are informed of the research protocol and after obtention of parental consent, the baby is included. The newborn is admitted in the neonatology unit and randomised in one of the three phototherapy devices group. Plasmatic bilirubin levels are checked at 6,12 and 24 and 48 hours of phototherapy. At 12 hours of phototherapy, a biological checking is performed to address the etiology of the jaundice. The next plasmatic bilirubin level is performed at 72h after inclusion. During phototherapy treatment the baby is continuously monitored. Phototherapy is stopped when bilirubin level is below 200µmol/l. If the bilirubin level is increasing under one of this ramps or does not decrease at H24, the baby will be immediately move on intensive phototherapy and participation at the research protocol interrupted. Twenty four hours after the end of phototherapy treatment, plasmatic bilirubin level is checked to confirm the end of jaundice and statement is made for jaundice origin. The total duration of participation of a baby at this study is 72 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Weeks and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Conjugated bilirubin level at 25µmol/l or more

• Total bilirubin level over 300µmol/l indicating "intensive phototherapy"

• Baby treated by phototherapy in the days before inclusion

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperbilirubinemia

Intervention

Device:
• Phototherapy
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.

Locations

Country	Name	City	State
France	CNRHP, Saint Antoine Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. Erratum in: Pediatrics. 2004 Oct;114(4):1138. — View Citation

Bertini G, Dani C, Pezzati M, Rubaltelli FF. Prevention of bilirubin encephalopathy. Biol Neonate. 2001;79(3-4):219-23. Review. — View Citation

Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41. — View Citation

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. Epub 2007 Feb 13. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Grohmann K, Roser M, Rolinski B, Kadow I, Müller C, Goerlach-Graw A, Nauck M, Küster H. Bilirubin measurement for neonates: comparison of 9 frequently used methods. Pediatrics. 2006 Apr;117(4):1174-83. — View Citation

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. — View Citation

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

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. — View Citation

Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N Engl J Med. 2008 Feb 28;358(9):920-8. doi: 10.1056/NEJMct0708376. Review. — View Citation

Maisels MJ, Newman TB. Surveillance of severe neonatal hyperbilirubinemia: a view from south of the border. CMAJ. 2006 Sep 12;175(6):599. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shapiro SM. Bilirubin toxicity in the developing nervous system. Pediatr Neurol. 2003 Nov;29(5):410-21. Review. — View Citation

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. Review. — View Citation

Stokowski LA. Fundamentals of phototherapy for neonatal jaundice. Adv Neonatal Care. 2006 Dec;6(6):303-12. Review. Erratum in: Adv Neonatal Care. 2007 Apr;7(2):65. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilirubinemia		24 hours	No
Secondary	Evolution of bilirubinemia according to the device used		6, 12,24, 48, 72 hours	No
Secondary	Hyperbilirubinemia rebound according to the device used		24 and 48 hours after discontinuation	No