Hyperbilirubinemia Clinical Trial
— DELFOfficial title:
Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CNRHP, Saint Antoine Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00360204 -
Improving Health Outcomes for New Mothers and Babies
|
Phase 3 | |
Completed |
NCT00383318 -
Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
|
N/A | |
Completed |
NCT00115544 -
Safety and Pharmacology of Stanate
|
Phase 2 | |
Completed |
NCT01622699 -
Implementation of a Transcutaneous Bilirubinometer
|
N/A | |
Terminated |
NCT00741117 -
Conjugated Hyperbilirubinemia and Pulse Oximetry
|
N/A | |
Completed |
NCT00288600 -
Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
|
Phase 4 | |
Completed |
NCT02774434 -
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
|
N/A | |
Completed |
NCT01550627 -
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
|
Phase 0 | |
Completed |
NCT00653874 -
Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates
|
Phase 3 | |
Recruiting |
NCT03564678 -
Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia
|
Phase 2 | |
Recruiting |
NCT04897113 -
Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
|
N/A | |
Recruiting |
NCT01944696 -
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
|
N/A | |
Completed |
NCT00635375 -
Comparative Study of Phototherapy for Hyperbilirubinemia
|
N/A | |
Completed |
NCT03195998 -
Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
|
||
Terminated |
NCT02685189 -
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
|
||
Completed |
NCT02446951 -
Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department
|
||
Completed |
NCT04271098 -
The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries
|
||
Completed |
NCT02691156 -
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
|
||
Completed |
NCT00004382 -
Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
|
Phase 2 | |
Completed |
NCT00004381 -
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
|
Phase 2 |