A pilot trial testing the feasibility of administering D-penicillamine to extremely low birth weight neonates.

OBJECTIVE: We enterally administered a 14-day course of 3-mercapto-D-valine (D-penicillamine) to five extremely low birth weight (ELBW) neonates, as a step toward assessing this therapy as a means of reducing the incidence or severity of retinopathy of prematurity (ROP). METHODS: The study drug (100...

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Publicado en:Journal of Perinatology Vol. 26; no. 2; pp. 120 - 125
Autores principales: Christensen RD, Alder SC, Richards SC, Horn JT, Lambert DK, Baer VL
Formato: research tables/charts Journal Article
Publicado: Springer Nature Feb2006
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Feb2006
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      pub: Springer Nature
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        10.1038/sj.jp.7211440
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        atl: A pilot trial testing the feasibility of administering D-penicillamine to extremely low birth weight neonates.
      aug:
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          Christensen RD
          Alder SC
          Richards SC
          Horn JT
          Lambert DK
          Baer VL
      sug:
        subj:
          Infant, Very Low Birth Weight
          Penicillamine Administration and Dosage
          Penicillamine Adverse Effects
          Retinopathy of Prematurity Prevention and Control
          Birth Weight
          Dose-Response Relationship, Drug
          Drug Administration Schedule
          Female
          Gestational Age
          Infant, Newborn
          Intubation, Gastrointestinal
          Male
          Pilot Studies
          Prospective Studies
          Risk Assessment
          Treatment Outcomes
          Human
          Infant, Newborn: birth-1 month
          Female
          Male
      ab: OBJECTIVE: We enterally administered a 14-day course of 3-mercapto-D-valine (D-penicillamine) to five extremely low birth weight (ELBW) neonates, as a step toward assessing this therapy as a means of reducing the incidence or severity of retinopathy of prematurity (ROP). METHODS: The study drug (100 mg/ml) was given by nasogastric tube at a dose of 100 mg/k every 8 h for three days, and then 50 mg/k once per day for 11 additional days. Logbooks were maintained by the bedside nurses to record signs of possible immediate intolerance. Laboratory tests assessed hepatic, renal, and hematologic toxicity. ROP was scored according to the ICROP guidelines. Comparisons were with a cohort of 139 consecutive recent neonates of the same birth weight and gestational age range. RESULTS: Five neonates were enrolled in the study, and all received the full course of study drug as planned. Signs of immediate intolerance of the study drug were not observed in any. The study patients did not have a higher incidence, than that of the cohort group, in creatinine elevation, thrombocytopenia, neutropenia, hyperbilirubinemia, or abnormal liver function test. Four of the five had no ROP and one developed transient stage 1, compared with a 54% occurrence of ROP in the cohort. CONCLUSIONS: It is feasible to enterally administer a 14-day course of 3-mercapto-D-valine to ELBW neonates and the suspension appears to be well tolerated. These results suggest that phase II safety and preliminary efficacy trials can be undertaken.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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