Multi-center studies
The neonatology department of the Hannover medical School (MHH) participates in various multi-center studies, which are described below. Due to the large number of patients who can be recruited from different hospitals under exactly the same conditions, multi-center studies make it possible to answer highly topical, special questions in the field of premature infant medicine in a much more timely manner.
Participation in one of the studies is, of course, voluntary and only after detailed verbal information and written informed consent from the parents. Once consent has been given, it can be withdrawn at any time without giving reasons.
The RESIST Cluster of Excellence is investigating why some people are more seriously ill with viral or bacterial infections than others. Newborns and premature babies represent such a risk group. About a quarter of all children born before 32 weeks of gestation develop a severe infection in infancy. Our knowledge of how immune programming in preterm infants differs from that in mature infants and adults has been very limited. There is growing evidence that the developing gut microbiome may be an important source of infection, on the one hand, and may also play an important role in postnatal maturation of the immune system, on the other. The goal of studying preterm infants born before the completed 33rd week of gestation is to better understand the interdependencies between the baby's immune phenotype and the coevolution of the gut microbiome in order to target the effects of the gut microbiota on the development of human immunity in a preventive and sustainable manner.
German Neonatal Network
The long-term effects of genetic, clinical and social risk factors and the influence of center-specific treatment strategies on the later development of preterm infants will be investigated in all preterm infants with a birth weight < 1000 g.
The German Neonatal Network started patient recruitment on 01.01.2009. It is planned to include more than 20,000 preterm infants with a birth weight < 1000 g in the study and to follow them up over a period of 6 years.
The study is funded by the German Federal Ministry of Education and Research (BMBF).
PRIMAL - Immunitation at the beginning of life
Intestinal dysbiosis is associated with an increased risk of various diseases such as infections, bronchial asthma, allergies, obesity, diabetes and neuropsychological disorders. Premature infants are at increased risk of developing gut dysbiosis.
The PRIMAL study is evaluating the efficacy of probiotics in preventing gut dysbiosis in very young preterm infants with a gestational age of 28+0 to 32+6 weeks' gestation at birth. Recruitment of a total of 650 preterm infants has been completed and follow-up until 2 years of age is ongoing.
The study is funded by the German Federal Ministry of Education and Research (BMBF).
Closed-loop automated control of inspiratory oxygen fraction (FiO2) Extremely immature preterm infants <28 weeks gestation at birth require ventilation / respiratory support and supplemental oxygen if necessary after birth. Nevertheless, oxygen saturation drops or periods of excessive oxygen saturation often occur, which may be associated with long-term sequelae such as retinopathy praematurorum or developmental delays.
The FiO2-C study is investigating whether automating oxygen delivery based on the infant's oxygen saturation reduces the frequency of deviations from the saturation target range compared with conventional manual control.
Enrollment began in April 2018, and a total of >2000 preterm infants with a gestational age of 23 0/7 to 27 6/7 weeks' gestation at birth will be included.
The study is funded by the German Federal Ministry of Education and Research (BMBF).
Optimizing PEEP to the immature Lung
In preterm infants with a gestational age between 26 0/7 and 29 6/7 weeks gestation at birth, the use of two different PEEP (positive end-expiratory pressure) levels will be investigated. Either a lower PEEP level (5 cmH2O) or a higher PEEP level (8 cmH2O) will be used in the primary care setting. The aim is to verify whether under the higher PEEP level the need for intubation and mechanical ventilation within the first 5 days of life and the need for surfactant application is lower than under the lower PEEP level. This is a randomized, controlled multicenter study in which 8 other centers across Germany are participating in addition to the Hannover medical School (MHH). Patient recruitment has started, a total of 216 preterm infants will be included in the study and followed up at 2 years of age.