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Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

NCT02344225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-05-01

Study results available
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Summary

Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Caffeine citrate

Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)

DRUG

Ibuprofen

Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days

DRUG

Ketorolac

Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Food and Drug Administration (FDA)

    collaborator FED

  • State University of New York - Downstate Medical Center

    lead OTHER

Principal Investigators

  • Jacob V Aranda, MD, PhD · SUNY Downstate Medical Center, University Hospital of Brooklyn

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344225 on ClinicalTrials.gov