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
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