Metabolic acidosis Nutritional, Metabolic, Endocrine
Conditions
Interventions
Two trial arms are being compared:
1. Routine use of sodium bicarbonate infusion for episodes of metabolic acidosis (intervention)
2. No routine use of sodium bicarbonate infusion for episodes of meta
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Babies born between 23+0 and 30+6 weeks+days of gestation inclusive 2. Postmenstrual age less than 34+0 weeks+days 3. Metabolic acidosis defined as blood pH less than 7.2 with pCO2 that is low or normal for the clinical context and a low bicarbonate level 4. The parent’s verbal consent for the baby to participate in the trial has been documented in the baby’s medical notes and Investigator Site File
Exclusion criteria
Exclusion criteria: 1. Life-threatening condition, or significant congenital anomaly 2. Inborn error of metabolism (known or under active investigation) 3. Prior treatment with sodium bicarbonate unless in the context of cardiopulmonary resuscitation or if used as a substitute for normal saline in arterial line infusion. 4. Current episode of metabolic acidosis immediately follows cardiopulmonary resuscitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To evaluate the effect of sodium bicarbonate on survival to discharge from neonatal care without major morbidity in preterm babies with metabolic acidosis. Primary outcome measures: Survival without major morbidity, with major morbidity defined as any of the following up to discharge from neonatal care or 40 weeks postmenstrual age (whichever is sooner): 1. Bronchopulmonary dysplasia (BPD) (defined as any respiratory or ventilatory support or supplemental oxygen at 36 weeks postmenstrual age) 2. Treatment for retinopathy of prematurity (ROP) (defined as cryotherapy, laser therapy or injection of anti-VEGF therapy for retinopathy of prematurity in either or both eyes) 3. Major brain injury (grade 3 / 4 IVH, periventricular leukomalacia (PVL) or post haemorrhagic ventricular dilatation requiring intervention) 4. Late-onset sepsis (defined as one or more episodes of a positive blood or cerebrospinal fluid culture with either a pure or mixed growth of a known pathogenic organism after the first 72 hours following birth) 5. Severe necrotising enterocolitis (defined as necrotising enterocolitis confirmed at surgery) 6. Major surgery (defined as any major surgical procedure recorded during neonatal admission) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objective: To evaluate the impact of sodium bicarbonate on survival without moderate to severe neurodevelopmental impairment at 24 months of age corrected for prematurity. Secondary outcome measure: Survival without moderate to severe neurodevelopmental impairment, including gross motor, vision and hearing impairment measured using a validated parent-report questionnaire, and cognitive and language impairment measured using the Parent Report of Children’s Abilities - Revised (PARCA R) at 24 months of age corrected for prematurity Other secondary objectives: To evaluate the impact of sodium bicarbonate on death and individual major morbidities during neonatal care, duration of neonatal unit stay and acceptability. Other secondary outcome measures: 1. Death up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 2. Bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age 3. Treatment for retinopathy of prematurity up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 4. Major brain injury (grade 3 / 4 IVH, periventricular leukomalacia (PVL) or post haemorrhagic ventricular dilatation requiring intervention) up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 5. Late-onset sepsis up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 6. Severe necrotising enterocolitis (necrotising enterocolitis confirmed at surgery or resulting in death) up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 7. Major surgery up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 8. Pulmonary haemorrhage resulting in increase in ventilatory requirements or blood transfusion (described using summary statistics only) up to discharge from neonatal care or reaching 40 weeks postmenstrual age (whichever is sooner) 9. Receipt | — |
Countries
England, United Kingdom
Contacts
Public ContactCatherine Thompsett
Outcome results
None listed