Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration.
OBJECTIVE
The Increased Flow Utilizing Subcutaneously-Enabled (INFUSE)-Pediatric Rehydration Study was designed to assess efficacy, safety, and clinical utility of recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous rehydration in children 2 months to 10 years of age.


METHODS
Patients with mild/moderate dehydration requiring parenteral treatment in US emergency departments were eligible for this phase IV, multicenter, single-arm study. They received subcutaneous injection of 1 mL rHuPH20 (150 U), followed by subcutaneous infusion of 20 mL/kg isotonic fluid over the first hour. Subcutaneous rehydration was continued as needed for up to 72 hours. Rehydration was deemed successful if it was attributed by the investigator primarily to subcutaneous fluid infusion and the child was discharged without requiring an alternative method of rehydration.


RESULTS
Efficacy was evaluated in 51 patients (mean age: 1.9 years; mean weight: 11.2 kg). Initial subcutaneous catheter placement was achieved with 1 attempt for 46/51 (90.2%) of patients. Rehydration was successful for 43/51 (84.3%) of patients. Five patients (9.8%) were hospitalized but deemed to be rehydrated primarily through subcutaneous therapy, for a total of 48/51 (94.1%) of patients. No treatment-related systemic adverse events were reported, but 1 serious adverse event occurred (cellulitis at infusion site). Investigators found the procedure easy to perform for 96% of patients (49/51 patients), and 90% of parents (43/48 parents) were satisfied or very satisfied.


CONCLUSIONS
rHuPH20-facilitated subcutaneous hydration seems to be safe and effective for young children with mild/moderate dehydration. Subcutaneous access is achieved easily, and the procedure is well accepted by clinicians and parents.
Allen
Coburn H
CH
Section of Emergency Medicine,Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas 77030, USA. challen@texaschildrenshospital.org
Etzwiler
Lisa S
LS
Miller
Melissa K
MK
Maher
George
G
Mace
Sharon
S
Hostetler
Mark A
MA
Smith
Sharon R
SR
Reinhardt
Neil
N
Hahn
Barry
B
Harb
George
G
D002648:Child; D002675:Child, Preschool; D003681:Dehydration / Q000628:therapy*; D005260:Female; D006801:Humans; D006821:Hyaluronoglucosaminidase / Q000008:administration & dosage* / Q000009:adverse effects; D007223:Infant; D007260:Infusion Pumps; D055104:Infusions, Subcutaneous / Q000009:adverse effects; D007279:Injections, Subcutaneous; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D015532:Rehydration Solutions / Q000008:administration & dosage*
D011994:Recombinant Proteins; D015532:Rehydration Solutions; D006821:Hyaluronoglucosaminidase