D-Penicillamine for preventing retinopathy of prematurity in preterm infants

Phelps D, Lakatos L, Watts J

Published Online:

January 21, 2009

The eye disease of premature infants called retinopathy of prematurity continues to be a serious problem. The drug d-penicillamine, given by mouth, is used to treat iron or copper or other heavy metal poisoning. In research to learn if the drug given intravenously might help another problem that premature infants have (high bilirubin), the eye disease seemed to be less. Therefore, the first tests of using intravenous d-penicillamine were done in premature infants, and it looked like it may be helpful. Much more testing must be done before we will know if it is truely useful and safe, but these may not happen. At this time, the drug is no longer being made for intravenous use. Future research will have to either test oral d-penicillamine, or identify a source of the intravenous form.

Abstract (click to read)

Background:

Retinopathy of prematurity remains a common problem. A low rate of this disorder was unexpectedly observed among infants treated with intravenous d-penicillamine to prevent hyperbilirubinemia. This observation led to the investigation of its use to prevent retinopathy of prematurity.

Objectives:

To answer the question: Among very low birth weight infants, what is the effect of prophylactic administration of d-penicillamine on the incidence of acute ROP or severe ROP, and side effects including death?

Search strategy:

Searches were made of multiple electronic databases, previous reviews including cross references, abstracts, conference/symposia proceedings, and expert informants. The search was updated to November 2000.

Selection criteria:

Randomized or quasi-randomized controlled trials that administered d-penicillamine to infants less than 2000g birth weight within the day following birth were considered relevant to this review. Additional case series were examined for potential side effects.

Data collection and analysis:

Data on clinical outcomes were excerpted by 3 reviewers independently, and consensus reached. Data analysis was conducted according to the standards of the Neonatal Cochrane Review Group.

Main results:

Two randomized trials on the effects on ROP were identified. When combined, they showed a significantly lower incidence of acute ROP in the treated infants, relative risk of 0.09, 95% CI [0.01,0.71]. Severe stages of ROP could not be analyzed. There was no effect on death rates, relative risk 0.99 95% CI [0.70,1.39]. No side effects were reported, and follow up at one year revealed no significant differences in spasticity or developmental delay, although there were more rehospitalizations among the controls. In other reports of using d-penicillamine in over 140 infants for hyperbilirubinemia, skin rashes were reported in 2 infants and one had vomiting that may have been related.

Authors' conclusions:

D-penicillamine is unlikely to affect survival, and may reduce the incidence of acute ROP among survivors. Studies to date justify further investigation of this drug in a broader population; careful attention to possible side effects is needed.

This record should be cited as:

Phelps D, Lakatos L, Watts J. D-Penicillamine for preventing retinopathy of prematurity in preterm infants. Cochrane Database of Systematic Reviews 2001, Issue 1. Art. No.: CD001073. DOI: 10.1002/14651858.CD001073

Assessed as up to date:

November 13, 2000

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Primary Review Group:

Neonatal Group

Health topics:

Neonatal care > Retinopathy of prematurity

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

D-Penicillamine for preventing retinopathy of prematurity in preterm infants

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