A two-year follow-up of neonates with presumed sepsis treated with recombinant human granulocyte colony-stimulating factor during the first week of life☆,☆☆,★,★★

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Abstract

We have previously reported that recombinant human granulocyte colony-stimulating factor was well tolerated and resulted in sustained neutrophilia and improvement of neutrophil functions in newborn infants with presumed sepsis. We now report a 2-year follow-up on 21 of the initial cohort of 28 patients. Treatment with recombinant human granulocyte colony-stimulating factor in neonates with presumed sepsis was not associated with any long-term adverse hematologic, immunologic, or developmental effects. (J PEDIATR 1996;128:135-7)

Section snippets

METHODS

Twenty-eight children were previously enrolled as part of a prospective, controlled, randomized study to assess rhG-CSF therapy in neonates with presumed sepsis.1 These newborn infants (26 to 40 weeks gestational age) with presumed bacterial sepsis within the first 3 days of life were random assigned to receive placebo or varying doses of rhG-CSF (1.0, 5.0, or 10.0 μg/kg every 24 hours or 5.0 or 10.0 μg/kg every 12 hours) for 3 days. Patients were enrolled in this

follow-up study after informed

Demographics

Families of infants who received rhG-CSF or placebo in the neonatal period were contacted for follow-up evaluation (median age 24.6 months, range 15.5 to 36 months). Twenty-one of 28 patients (18 boys) were available for evaluation. Mean chronologic age was 24.6 ± 1.7 months with a range of 15.5 to 36 months.

Hematologic screening

The hematologic profile of infants previously treated with rhG-CSF for presumed neonatal sepsis was evaluated by routine complete blood counts, manual differential, calculation of the

DISCUSSION

Treatment with rhG-CSF in adults and children with various congenital neutropenia syndromes or with acquired, chemotherapy-induced neutropenia results in a dose-dependent increase of the neutrophil count. Use of rhG-CSF has been generally well tolerated in children.4 Although therapeutic doses of rhG-CSF range from 2.5 to 10 μg/kg per day, doses of more than 100 μg/kg have been given without dose-limiting toxic effects.4

The delays in gross motor and perceptual/fine motor development seen were

Acknowledgements

We thank Linda Rahl for her editorial and critical review, and Sally Anderson and Renee Dulak for their assistance in preparation of this manuscript. We also thank Amgen Inc. for their support and collaboration in this follow-up study.

References (6)

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From the Division of Hematology/Oncology, Children's Hospital of Orange County, Orange, California, and the Department of Pediatric Hematology/Oncology, University of Connecticut Health Center, Storrs

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Supported by grants from the Pediatric Cancer Research Foundation, the Walden W. and Jean Young Shaw Foundation, the CHOC Research and Education Foundation, and Amgen Inc.

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Reprint requests: Mitchell S. Cairo, MD, Director, Hematology/Oncology Research and Blood and Bone Marrow Transplantation, Children's Hospital of Orange County, 455 S. Main St., Orange, CA 92668.

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0022-3476/96/$5.00 + 0 9/24/68816

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