Participating in scientific research at the NICU Participating in scientific research at the NICU

Studies at the NICU

The staff at the NICU need your help if they are to continue improving the chances of newborn babies in the years ahead. We have provided a brief description in this leaflet of the most important studies in our department with regard to which we are allowed to contact you. This could be before and/or after the birth of your child. If your child spends a little longer in the NICU, we may contact you about multiple studies. You can decide whether or not you wish to participate on a study-by-study basis. We keep this leaflet as up-to-date as possible. However, we may ask you to take part in a study that is not mentioned in this leaflet.

Studies that start after the birth

Albino study

• Who: Children with a gestational age of more than 36 weeks who experience oxygen deprivation at birth.
• What: The study examines the effects and safety of administering medication (Allopurinol) to reduce the effects of oxygen deprivation.

Studies that start in the first week of life

eMINDS study

• Who: Children born at less than 28 weeks’ gestational age.
• What: The study examines whether stool composition can predict the likelihood of enteritis or sepsis. Stool samples are collected for the first 29 days of life for this study.

From mum to bum

• Who: Children born at less than 30 weeks’ gestational age.
• What: The study examines the effect of breast milk on the composition of bacteria in the intestines and their contribution to the digestion of food.

Prico study

• Who: Children born at less than 28 weeks’ gestational age on CPAP or a ventilator.
• What: When oxygen levels in the child’s blood rise or fall, the ventilator automatically adjusts the amount of oxygen administered.

Doxapram study

• Who: Children born at less than 29 weeks’ gestational age who, despite respiratory support, still experience pauses in breathing.
• What: The study examines the long-term effects of the medicine Doxapram (effective against pauses in breathing).

FIT-PIV/FIT-05 study

• Who: Children born at less than 32 weeks’ gestational age.
• What: The study examines the effect of adding insulin to the diet of premature babies on their digestions.

Studies that start after the first week of life

NoGBS study

• Who: Children aged between 0-3 months with sepsis and/or meningitis with group B haemolytic streptococcus (GBS) or E. Coli.
• What: The study examines the risk factors for the acquisition of such infections.

SOS BPD study

• Who: Children born at less than 32 weeks’ gestational age who still require oxygen at 36 weeks.
• What: Determining the oxygen level in the blood where additional oxygen is required.

Parents’ FAQs

What is research and why is it important?

Our aim in conducting research is to gain a better understanding of the effects of a condition or a treatment on the body of a newborn. We sometimes compare an existing treatment with a new one that we strongly suspect is simply slightly better and/or safer. We do this in an attempt to improve the chances of ill newborns.

Is research safe?

All studies are approved by the NICU doctors and nurses, Isala’s medical ethics committee and the government. This way we ensure that research is carried out only when it is safe and important.

Am I obliged to take part in research?

No, participation in research is voluntary and will take place only with your (written) consent. If you decide not to consent, this will in no way adversely affect the care and treatment your child receives.

Can my child take part in more than one study?

Yes, because in a number of studies your child will barely notice the test, if at all. Examples include analysing stools or urine. We will also monitor your child carefully to make sure that the combination of studies is not placing too much strain on him or her.

Who will contact us about participating in research?

If your child is eligible for participation, the researcher will tell you about the study in person and ask you for your consent. This therefore means that you could be contacted multiple times by different researchers.

Thank you!

Without your support and trust, we at the NICU cannot carry out research to improve the chances of ill newborn babies all over the world. On behalf of all doctors, nurses and children of the future, thank you!

If you have any questions about studies conducted at the NICU/Neonatal department, please contact any of the following members of the Isala research team:

• Dr M.A.C. Hemels, paediatrician and neonatologist
• Dr M.D. de Groot-van der Mooren, paediatrician and neonatologist
• A. Giezen, NICU research nurse
• W. Slager, NICU research nurse

Contact

If you have any other questions, please call the secretariat of:

Isala 
Neonatal intensive care unit (NICU)
Dr. van Heesweg 2
8025 AB Zwolle
088 624 50 55