None listed
Conditions
Brief summary
The DExTROCord Study aims to investigate if hormones that control blood sugar levels collected from umbilical cord blood can predict the risk of hypoglycaemia in the first 24 hours of life and hyperglycaemia in the first 7 days of life in preterm infants. Preterm infants are at risk of having dysglycaemia after birth, which can affect their childhood neurodevelopmental outcomes of babies or lead to issues during their admission in the internsive care unit. Being able to predict which babies will eventually have hypoglycaemia and hyperglycaemia will optimise their management and prevent these adverse outcomes. There have been no other studies that have investigated whether hormones collected from the umbilical cord blood of babies are associated with dysglycaemia. Therefore, the results of the DExTROCord Study will advance the knowledge in this research area.
Interventions
The DExTROCord Study is a prospective observational cohort study with the aim of determining the relationship between umbilical cord blood hormones of glucose homeostasis and dysglycaemia (hypoglycaemia and hyperglycaemia) in infants born at less than 32 weeks' gestation. The primary aim is to evaluate whether these hormones predict their risk of hypoglycaemia in the first 24 hours of life. The secondary aim of this study is to determine the relationship between these umbilical cord blood hormones and hyperglycaemia in the first 7 days of life. Umbilical cord blood samples from eligible infants will be collected at birth. These samples are currently not a part of usual care for these infants. The study will employ a waiver of consent approach for the collection, preservation, and temporary storage of these umbilical cord blood samples to ensure that the study population is a representative sample of infants born at less than 32 weeks' gestation. After obtaining parental consent for their infant to continue participating in the study, the umbilical cord blood sample will be analysed for glucose, insulin, and cortisol levels. Maternal and neonatal data, including serum blood glucose levels for the first 7 days of life of participants, will be collected from their respective electronic medical records. Maternal data include relevant information such as timing of labour and rupture of membranes, diagnosis of fetal growth restriction, diagnosis of gestational diabetes mellitus and management, and diagnosis of chorioamnionitis. Neonatal data include relevant information such as gestational age at birth, birthweight and associated z-score, sex, diagnosis of fetal growth restriction, level of resuscitation required at birth, and management of hypoglycaemia. The study aims to recruit a minimum of 100 infants over a period of 2 years from a single tertiary neonatal intensive care unit.
Sponsors
Eligibility
Inclusion criteria
This study will comprise of inborn infants born at less than 32 weeks’ gestation. All modes of delivery will be included.
Exclusion criteria
There is no specific exclusion criteria in this study.