Randomized Controlled Trial

. 2008 Oct 30;359(18):1885-96.

doi: 10.1056/NEJMoa0803024.

Aggressive vs. conservative phototherapy for infants with extremely low birth weight

Collaborators, Affiliations

Collaborators

NICHD Neonatal Research Network:
A Jobe, I Adams-Chapman, C Bauer, A M Dusick, R Goldstein, R J Heyne, S R Hintz, G Myers, A Pappas, M Peralta-Carcelen, J Steichen, Y E Vaucher, R Dillard, L K Washburn, D Wilson-Costello, W Oh, A R Laptook, B R Vohr, A Hensman, L Noel, A A Fanaroff, M C Walsh, D Wilson-Costello, N S Newman, B S Siner, R N Goldberg, C M Cotten, R Goldstein, K Auten, M Lohmeyer, B J Stoll, I Adams-Chapman, E Hale, J A Lemons, B B Poindexter, A M Dusick, D D Appel, D Herron, L Miller, L Richard, L L Wright, R D Higgins, W K Poole, A Das, B Hastings, E McClure, J Newman, R L Perritt, Q Yao, C P Huitema, K Zaterka-Baxter, D K Stevenson, K P Van Meurs, S R Hintz, M B Ball, W A Carlo, M Peralta-Carcelen, M V Collins, S S Cosby, V Phillips, N N Finer, Y E Vaucher, M R Rasmussen, D Kaegi, K Arnell, C Demetrio, M G Fuller, C Henderson, W Rich, E F Donovan, K Schibler, J Steichen, B Alexander, C Grisby, M Mersmann, H Mincey, J Shively, T Gratton, C R Bauer, S Duara, R Everett-Thomas, R Guillet, D L Phelps, G Myers, L Reubens, D Hust, R Jensen, E Burnell, W A Salhab, P Sanchez, C R Rosenfeld, R J Heyne, J Hickman, G Hensley, N A Miller, J Morgan, J E Tyson, K Kennedy, B H Morris, C Pedroza, P J Bradt, P W Evans, L L Whiteley, E G Akpa, P A Cluff, A E Lis, G E McDavid, C Y Franco, M Currence, N I Alaniz, P L Tate, S L Wright, T M O'Shea, L K Washburn, N J Peters, B G Jackson, S Shankaran, Y Johnson, A Pappas, R Bara, G Muran, D Kennedy, R A Ehrenkranz, P Gettner, H Jacobs, C Butler, P Cervone, M Konstantino, E Romano

Affiliation

¹ University of Texas Medical School, Houston, TX 77030, USA.

PMID: 18971491
PMCID: PMC2821221
DOI: 10.1056/NEJMoa0803024

Randomized Controlled Trial

Aggressive vs. conservative phototherapy for infants with extremely low birth weight

Brenda H Morris et al. N Engl J Med. 2008.

. 2008 Oct 30;359(18):1885-96.

doi: 10.1056/NEJMoa0803024.

Collaborators

NICHD Neonatal Research Network:
A Jobe, I Adams-Chapman, C Bauer, A M Dusick, R Goldstein, R J Heyne, S R Hintz, G Myers, A Pappas, M Peralta-Carcelen, J Steichen, Y E Vaucher, R Dillard, L K Washburn, D Wilson-Costello, W Oh, A R Laptook, B R Vohr, A Hensman, L Noel, A A Fanaroff, M C Walsh, D Wilson-Costello, N S Newman, B S Siner, R N Goldberg, C M Cotten, R Goldstein, K Auten, M Lohmeyer, B J Stoll, I Adams-Chapman, E Hale, J A Lemons, B B Poindexter, A M Dusick, D D Appel, D Herron, L Miller, L Richard, L L Wright, R D Higgins, W K Poole, A Das, B Hastings, E McClure, J Newman, R L Perritt, Q Yao, C P Huitema, K Zaterka-Baxter, D K Stevenson, K P Van Meurs, S R Hintz, M B Ball, W A Carlo, M Peralta-Carcelen, M V Collins, S S Cosby, V Phillips, N N Finer, Y E Vaucher, M R Rasmussen, D Kaegi, K Arnell, C Demetrio, M G Fuller, C Henderson, W Rich, E F Donovan, K Schibler, J Steichen, B Alexander, C Grisby, M Mersmann, H Mincey, J Shively, T Gratton, C R Bauer, S Duara, R Everett-Thomas, R Guillet, D L Phelps, G Myers, L Reubens, D Hust, R Jensen, E Burnell, W A Salhab, P Sanchez, C R Rosenfeld, R J Heyne, J Hickman, G Hensley, N A Miller, J Morgan, J E Tyson, K Kennedy, B H Morris, C Pedroza, P J Bradt, P W Evans, L L Whiteley, E G Akpa, P A Cluff, A E Lis, G E McDavid, C Y Franco, M Currence, N I Alaniz, P L Tate, S L Wright, T M O'Shea, L K Washburn, N J Peters, B G Jackson, S Shankaran, Y Johnson, A Pappas, R Bara, G Muran, D Kennedy, R A Ehrenkranz, P Gettner, H Jacobs, C Butler, P Cervone, M Konstantino, E Romano

Affiliation

¹ University of Texas Medical School, Houston, TX 77030, USA.

PMID: 18971491
PMCID: PMC2821221
DOI: 10.1056/NEJMoa0803024

Abstract

Background: It is unclear whether aggressive phototherapy to prevent neurotoxic effects of bilirubin benefits or harms infants with extremely low birth weight (1000 g or less).

Methods: We randomly assigned 1974 infants with extremely low birth weight at 12 to 36 hours of age to undergo either aggressive or conservative phototherapy. The primary outcome was a composite of death or neurodevelopmental impairment determined for 91% of the infants by investigators who were unaware of the treatment assignments.

Results: Aggressive phototherapy, as compared with conservative phototherapy, significantly reduced the mean peak serum bilirubin level (7.0 vs. 9.8 mg per deciliter [120 vs. 168 micromol per liter], P<0.01) but not the rate of the primary outcome (52% vs. 55%; relative risk, 0.94; 95% confidence interval [CI], 0.87 to 1.02; P=0.15). Aggressive phototherapy did reduce rates of neurodevelopmental impairment (26%, vs. 30% for conservative phototherapy; relative risk, 0.86; 95% CI, 0.74 to 0.99). Rates of death in the aggressive-phototherapy and conservative-phototherapy groups were 24% and 23%, respectively (relative risk, 1.05; 95% CI, 0.90 to 1.22). In preplanned subgroup analyses, the rates of death were 13% with aggressive phototherapy and 14% with conservative phototherapy for infants with a birth weight of 751 to 1000 g and 39% and 34%, respectively (relative risk, 1.13; 95% CI, 0.96 to 1.34), for infants with a birth weight of 501 to 750 g.

Conclusions: Aggressive phototherapy did not significantly reduce the rate of death or neurodevelopmental impairment. The rate of neurodevelopmental impairment alone was significantly reduced with aggressive phototherapy. This reduction may be offset by an increase in mortality among infants weighing 501 to 750 g at birth. (ClinicalTrials.gov number, NCT00114543.)

2008 Massachusetts Medical Society

PubMed Disclaimer

Conflict of interest statement

Dr. Fanaroff reports receiving consulting fees, and Dr. Guillet grant support, from Natus. No other potential conflict of interest relevant to this article was reported.

Figures

**Figure 1. Enrollment, Randomization, and Follow-up of the Study Patients**
There were no significant differences at baseline between infants with known and those with unknown neurodevelopmental status.

See this image and copyright information in PMC

References

1. Bratlid D. How bilirubin gets into the brain. Clin Perinatol. 1990;17:449–65. - PubMed
1. Cashore WJ. The neurotoxicity of bilirubin. Clin Perinatol. 1990;17:437–47. - PubMed
1. Lucey JF. Bilirubin and brain damage — a real mess. Pediatrics. 1982;69:381–2.
1. Watchko JF, Oski FA. Kernicterus in preterm newborns: past, present, and future. Pediatrics. 1992;90:707–15. - PubMed
1. Boggs TR, Jr, Hardy JB, Frazier TM. Correlation of neonatal serum total bilirubin concentrations and developmental status at age eight months: a preliminary report from the Collaborative Project. J Pediatr. 1967;71:553–60. - PubMed

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Grants and funding

LinkOut - more resources

Full Text Sources
Other Literature Sources
- The Lens - Patent Citations Database
Medical
- ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Aggressive vs. conservative phototherapy for infants with extremely low birth weight

Collaborators

Affiliation

Aggressive vs. conservative phototherapy for infants with extremely low birth weight

Authors

Collaborators

Affiliation

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical