Pentoxifylline to improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis

Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial - PROTECT Trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002548-26-IE

Enrollment

1800

Registered

2019-10-11

Start date

2020-12-16

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late onset sepsis & necrotising enterocolitis MedDRA version: 20.1 Level: LLT Classification code 10053598 Term: Late onset neonatal sepsis System Organ Class: 100000004862 MedDRA version: 20.1 Level: LLT Classification code 10028884 Term: Necrotising enterocolitis System Organ Class: 100000004856

Interventions

Product Name: Pentoxifylline Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PENTOXIFYLLINE CAS Number: 6493-05-6 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence of major congenital malformation(s) or chromosomal abnormalities or any other conditions considered likely to be incompatible with disability-free survival

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Survival without any disability at 24 months corrected age ;Secondary Objective: 2. Survival until discharge home and at follow-up 3. Any disability at 24 months 4. Disability by grade and type (motor, language, cognitive, etc) 5. Progression from Stage II to Stage IIIA/B NEC 6. Surgery for NEC 7. Duration of parenteral nutrition 8. Brain injury (intraventricular haemorrhage (IVH) or periventricular leukomalacia (PVL) 9. Duration of any mechanical ventilation 10. Chronic lung disease 11. Time to full enteral feeds 12. Retinopathy of prematurity 13. Length of hospital stay ;Primary end point(s): Primary outcome will be survival without any disability at 24 months corrected gestational age. Survival a) All infants discharged home alive b) All infants alive at follow-up Any disability at 24 months: Any disability assessed by the following assessments at 24 months corrected age a) Bayley-III and/or b) parent report on the Ages and Stages Questionnaire and/or c) a modified Short Health Status Questionnaire documenting either - major developmental delay, including language or speech problems, or - cerebral palsy with inability to walk unassisted at or after 2 years corrected age, or - severe visual loss (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes), or - deafness, requiring a hearing aid or cochlear implants;Timepoint(s) of evaluation of this end point: 24 months of age corrected for gestation	—

Measure

Time frame

Main Objective: 1. Survival without any disability at 24 months corrected age ;Secondary Objective: 2. Survival until discharge home and at follow-up 3. Any disability at 24 months 4. Disability by grade and type (motor, language, cognitive, etc) 5. Progression from Stage II to Stage IIIA/B NEC 6. Surgery for NEC 7. Duration of parenteral nutrition 8. Brain injury (intraventricular haemorrhage (IVH) or periventricular leukomalacia (PVL) 9. Duration of any mechanical ventilation 10. Chronic lung disease 11. Time to full enteral feeds 12. Retinopathy of prematurity 13. Length of hospital stay ;Primary end point(s): Primary outcome will be survival without any disability at 24 months corrected gestational age. Survival a) All infants discharged home alive b) All infants alive at follow-up Any disability at 24 months: Any disability assessed by the following assessments at 24 months corrected age a) Bayley-III and/or b) parent report on the Ages and Stages Questionnaire and/or c) a modified Short Health Status Questionnaire documenting either - major developmental delay, including language or speech problems, or - cerebral palsy with inability to walk unassisted at or after 2 years corrected age, or - severe visual loss (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes), or - deafness, requiring a hearing aid or cochlear implants;Timepoint(s) of evaluation of this end point: 24 months of age corrected for gestation

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Australia, Canada, Ireland, New Zealand, Singapore, Taiwan

Contacts

Public ContactMandy Jackson

Royal College of Surgeons in Ireland

mandyjackson@rcsi.com+35318093863

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026