Nebulised pentoxifylline for the prevention of chronic lung disease in extremely preterm infants

Does treating extremely preterm infants with inhaled Pentoxifylline vs Saline placebo lead to a reduction in chronic lung disease?

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000145909

Enrollment

Registered

2011-02-08

Start date

2011-03-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Chronic Lung Disease (Bronchopulmonary dyplasia) is a common and serious complication in extremely preterm infants below 28 weeks. In 2008 in Western Australia, over 120 infants were born at less than 28 weeks. 28% of the survivors developed Chronic lung disease. With it’s immunomodulatory effects, Pentoxifylline is emerging as a promising treatment for conditions such as sepsis, NEC and Chronic Lung disease. Whilst trials are encouraging for Pentoxifylline’s effect on Chronic lung disease; well organized, properly blinded trials have not been published. This trial aims to address this and discover whether nebulized pentoxifylline might help prevent bronchopulmonary dysplasia in extremely preterm infants.

Interventions

Nebulised Pentoxifylline at 20 mg/kg (1ml/kg), 6 hourly for 10 days. If still ventilated or requiring>= 30% oxygen 5 days after completing course, baby will receive a repeat 10 day course.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

23 Weeks to 27 Weeks

Healthy volunteers

Inclusion criteria

Preterm infants < 28 w GA will be eligible for enrolment if they require mechanical ventilation greater than or equal to 30% supplemental oxygen at 72 – 168 h of life and if written informed parental consent is given.

Exclusion criteria

Congenital malformations of the thorax (e.g. congenital diaphragmatic hernia, congenital cystic adenomatoid malformation of the lung, esophageal atresia) Major cardiac malformations. (Infants with persistent ductus arteriosus or hemodynamically non-significant atrial or ventricular septal defect may be included in the trial).

Outcome results