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Clinical Trials List

Protocol NumberDMR-1060115

2017-07-01 - 2022-12-31

Phase III

Not yet recruiting1

Recruiting1

ICD-10P77.1

Stage 1 necrotizing enterocolitis in newborn

ICD-10P77.2

Stage 2 necrotizing enterocolitis in newborn

ICD-10P77.3

Stage 3 necrotizing enterocolitis in newborn

ICD-10P77.9

Necrotizing enterocolitis in newborn, unspecified

ICD-9777.5

Necrotizing enterocolitis in fetus or newborn

Can Pentoxifylline improve long-term outcomes in preterm infants with sepsis or necrotizing enterocolitis? A pragmatic, randomized, placebo controlled trial.

Trial Applicant
Sponsor
Trial scale

Taiwan Single Center
Update

2025/08/19

Investigators and Locations

Principal Investigator Hung-Chih Lin Division of Pediatrics

China Medical University Hospital

Co-Principal Investigator

黃富槻 Division of Pediatrics
魯怡群未分科
Hsiao-Yu Chiu Division of Pediatrics
Hsiang-Yu Lin Division of Pediatrics
Ming-Lun Yeh Division of Pediatrics
陳映廷未分科

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator

CMU Children's Hospital

Co-Principal Investigator

魯怡群 Division of Pediatrics
Hsiao-Yu Chiu Division of Pediatrics
陳映廷 Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

peripheral circulation disturbance

Objectives

Primary Objective The primary objective is to determine: 1. Survival without any disability at 24 months corrected age

Test Drug

Pentoxifylline

Active Ingredient

Pentoxifylline

Dosage Form

injection

Dosage

100 mg/5mL ampoules

Endpoints

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

Inclution Criteria

Inclusion Criteria
1. Infants <29 weeks gestation within 6 hours of blood culture taken for suspected LOS or
NEC
2. Signed, written informed consent by a parent or a legal guardian

Exclusion Criteria

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

The Estimated Number of Participants

Taiwan

60 participants
Global

1800 participants