Dobutamine in haemodynamic insufficiency of extreme prematurity (v1)

• Research type

  Research Study

• Full title

  An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency in the immediate postnatal period

• IRAS ID

  135983

• Contact name

  Heike Rabe

• Contact email

  heike.rabe@bsuh.nhs.uk

• Sponsor organisation

  Servicio Madrileño de Salud (SERMAS)

• Eudract number

  2013-002845-12

• ISRCTN Number

  Not provided

• Clinicaltrials.gov Identifier

  Not provided

• Research summary

  NeoCirc-001- Dobutamine in haemodynamic insufficiency of extreme prematurity (v1)

  Sick newborn babies who are born too early are at risk of brain damage and other problems with their later development because of circulatory failure. Circulatory failure means that the tiny hearts of babies may not be sending the right supply of blood to important parts of the body, including the brain. This is because the conditions when living outside the womb make it harder for blood to be circulated compared to living inside and also because the muscles in the tiny babies’ hearts are still growing and not strong enough to help pump enough blood to the body. Babies born too early may take longer to adapt to living outside the womb and it is important for doctors to detect how well a baby is adapting and if there is circulatory failure.
  Often doctors use a drug called Dobutamine to support the babies’ circulation if they need it. The drug has been used for decades but has not been properly tested in babies born too early. The proposed study is the first of three studies, which will use a new age appropriate formulation of Dobutamine for the use in babies born too early. This study will observe the way how babies born between 24 and 32 weeks’ gestation with circulatory failure during the first three days of life are treated. If indicated they can be treated with the new Dobutamine. The babies will have extra ultrasound examinations of the heart and circulation. The study will look into how babies are handling the drug in their body. This will be done by taking two extra small blood samples. The overall aim is to get the new formulation approved for use in babies born too early.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/1426

• Date of REC Opinion

  7 Nov 2013

• REC opinion

  Further Information Favourable Opinion