Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Downstate Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Food and Drug Administration (FDA)
• Treatments: Caffeine; Caffeine citrate; Citric Acid; Ibuprofen; Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Neonates at high risk for ROP as outlined by the American Academy of Pediatrics, Section on Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion criteria are:

1. all infants with a birth weight of less than 1250 grams;

2. all infants with a gestational age of 28 weeks or less; and

3. all infants who required oxygen therapy and ventilator support within the first 2 days of life.

Exclusion Criteria:

• Exclusion criteria are:

1. major congenital malformations and or chromosomal anomalies including duct-dependent cardiac anomalies;

2. maternal antenatal NSAID exposure <72 hours before birth;

3. renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8 hours prior to randomization. Anuria is acceptable if infant is less than 24 hours of life;

4. platelet count <75,000.mm3;

5. clinical bleeding such as oozing from puncture sites; and

6. participation in other clinical drug trials while subject participates in this study and for 7 days after last dose of study drug.