What is the study about?

In the UK, over 100,000 babies need specialist neonatal care each year (1 in 7 live births). Respiratory illness necessitating ventilatory support is the most common pathology requiring intensive care. Babies born at <32 weeks’ gestational age are the most likely to need ventilation.

Pain in preterm babies is inadequately managed and under-researched. Morphine is frequently used for analgesia during ventilation as it is painful.

However, evidence suggests that morphine may not provide adequate analgesia and may adversely prolong the need for ventilation and time to reach full milk feeds. Additionally, babies given larger doses of morphine in early life have a higher risk of brain injury and poorer neurodevelopment and behavioral outcomes in later life. Despite this, due to lack of alternatives, morphine continues to be the most popular analgesic for ventilated babies.

We have designed a study to investigate whether dexmedetomidine, an alternative to morphine in adult and pediatric intensive care, can reduce the cumulative dose of morphine needed to provide analgesia in ventilated preterm babies. The study will recruit preterm babies born at <32 weeks’ gestation, babies will be assigned randomly to one of three study groups:

1. 120-hour infusions of dexmedetomidine (0.5mcg/kg/hour) + morphine,
2. 120-hour infusions of dexmedetomidine (0.25mcg/kg/hour) + morphine,
3. 120-hour infusions of matched placebo + morphine.

We will also measure potential benefits and safety of dexmedetomidine, pharmacokinetics and the short- and long-term adverse effects of these treatments.

Who can take part in the study?

Babies who are born at <32 weeks’ gestational age, and who may require ventilation for at least 48 hours and morphine infusion for analgesia, are potentially eligible to take part. 

What is being tested in the study?

We are testing two treatments:

1. 120-hour infusions of dexmedetomidine (0.5mcg/kg/hour) + morphine,
2. 120-hour infusions of dexmedetomidine (0.25mcg/kg/hour) + morphine.

What is this being compared to?

We are comparing the two treatments to ‘morphine infusion with a matched placebo’. The clinical team will not know which treatment group the babies are assigned to.

What are we trying to find out?

We are comparing the two treatments to ‘morphine infusion with a matched placebo’. The clinical team will not know which treatment group the babies are assigned to.

How many patients do we need?

240 babies from 15 UK Neonatal Intensive Care Units.

Funder

National Institute for Health and Care Research (NIHR)