Information for Hospitals

This section is dedicated to doctors and other health professionals involved with the Baby-OSCAR Trial.

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Introduction

Babies born preterm commonly have a condition called Patent Ductus Arteriosus (PDA). This is when the blood vessel (Ductus arteriosus, which allows during pregnancy, blood to bypass the baby's developing lungs and reach the mother's placenta), remains open after birth. The word 'patent' here means 'open'.

A PDA is associated with a number of very serious and life threatening complications which can include brain damage and chronic breathing difficulties.

Babies who are born extremely preterm (less than 29 weeks of pregnancy) are more likely to have a PDA.

In the UK, approximately 7,000 babies are born extremely preterm each year. Of these around 40% will have a PDA. In some, the condition will disappear on its own but in others treatment may be needed.

The condition can be treated with ibuprofen, but giving extremely preterm babies can result in significant complications.

Medical opinion is therefore divided on how best to care for extremely preterm babies with a PDA. Some doctors believe it is better to treat with ibuprofen as a precaution, but others believe it is better to wait until PDA symptoms appear. Treating all babies inevitably means some will be exposed unnecessarily to the potentially harmful side effects of ibuprofen, whilst not treating until symptoms develop may be too late, as the condition may already have caused irreversible damage.

Study Treatment

Babies will be randomly allocated to receive either treatment with ibuprofen or a matched placebo. Placebo (a harmless solution of weak salt water, known as saline) will be given to babies in the non-treatment group. The ibuprofen formulation that will be used in this study has been approved for the treatment of PDA in premature babies.

Neither parents nor staff caring for a baby will know which treatment has been allocated.  This is to make sure that the treatments are compared fairly, and to prevent the results of the study being biased.

Baby-OSCAR eligibility criteria

Inclusion criteria:

Babies will be considered eligible for inclusion in the trial if they are:

  • Born at 23+0 to 28+6 weeks of gestation
  • Less than 72 hours old

  • Confirmed by echocardiography to have a large PDA which:

    • is at least 1.5 mm in diameter (determined by gain optimised colour Doppler), and

    • has unrestrictive pulsatile (left to right) flow (ratio of flow velocity in PDA Maximum (Vmax) to Minimum (Vmin) > 2:1)) or, growing flow pattern (< 30% right to left), and no clinical concerns of pulmonary hypertension.

In addition:

  • The responsible clinician is uncertain about whether the baby might benefit from treatment to close the PDA

  • Written informed consent has been obtained from the parent(s).

Exclusion criteria

Babies will be excluded from participation in the trial if they have:

  • No realistic prospect of survival

  • Severe congenital anomaly

  • Clinical or echocardiography suspicion of congenital structural heart disease that contraindicates treatment with ibuprofen

  • Other conditions that would contraindicate the use of ibuprofen (active bleeding especially intracranial or gastrointestinal bleeding, coagulopathy, thrombocytopenia (platelet count <50,000), renal failure, life threatening infection, pulmonary hypertension, known or suspected necrotising enterocolitis (NEC))

  • Indomethacin, ibuprofen, or paracetamol administration after birth

Recruitment Target

The recruitment target is 730 babies over 82 months. The study was piloted in 5 neonatal units during July - Decemeber 2015, and is being rolled out to further sites across the country for Winter 2016/2017.

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This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Reference Number 11/92/15). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.