Preterm infant stabilisation
Conditions
Interventions
Physiological-Based Cord Clamping (PBCC)
stabilisation of the infant with the
umbilical cord intact and only clamp the cord when the infant is
cardiopulmonary stable using a purpose-built resuscitation table, the Concord.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria in this study are: • Infants born at a gestational age below 30 weeks in a participating centre. • Parental consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Significant congenital malformations. • Signs of acute placental abruption. • Total placenta praevia, anterior placenta praevia or invasive placentation (accreta/percreta). • Birth by emergency caesarean section (ordered to be executed within 15 minutes). • Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia Polycythemia Syndrome not treated with fetoscopic laser treatment. • Multiple pregnancy > 2 (triplets or higher order). • Decision documented to give palliative neonatal care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dichotomous outcome intact survival at NICU discharge is defined as survival without major cerebral injury (IVH >= grade 2 and/or PVL >= grade 2 and/or periventricular venous infarction) and/or NEC >= Bell stage 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure related Details of the stabilisation at birth, treatment failure, infant temperature at admission to the NICU, highest infant haemoglobin levels within 24 hours of age, occurrence of polycythemia. 2. Neonatal outcomes, short-term Apgar scores, ductal flow ratio at 1 hour of age combined with blood pressure measurement, intubation in first 72 hours, IRDS, use of surfactant, intravascular volume expansion in first 72 hours, inotropes in first 72 hours, pneumothorax, persistent ductus arteriosus for which medical intervention or surgical ligation is necessary, duration of phototherapy, proven early onset sepsis (clinical suspicion with positive blood culture), proven late onset sepsis (clinical suspicion with positive blood culture > 72 hours after delivery), necrotizing enterocolitis >= grade 2, surgical NEC: Necrotizing enterocolitis requiring surgical intervention (also if the patient was too unstable to undergo surgery), spontaneous focal intestinal perforation, number of red blood cell transfusions, intraventricular haemorrhage >= grade 2, periventricular leukomalacia >= grade 2, periventricular venous infarction, bronchopulmonary dysplasia, retinopathy of prematurity, mortality at 28 days postnatal age (PNA), 36 weeks postmenstrual age (PMA) and at hospital discharge, length of stay in NICU, length of stay in hospital 3. Maternal outcomes Maternal blood loss, postpartum haemorrhage > 1000 ml, placental weight, surgical site infection after caesarean section. 4. Neonatal outcomes, long-term Long-term neurodevelopmental outcomes assessed at 2 years corrected age: o Bayley Scales of Infant Development III (BSID-III-NL) o Mental Developmental Index (MDI) o Psychomotor Developmental Index (PDI) o Cerebral palsy and severity of CP o Hearing loss requiring hearing aids o Blindness o Behavioural problems (CBCL) The parents and the caregivers will be asked to fill in a questionnaire concerning their perception and appreciation | — |
Countries
Netherlands
Outcome results
None listed