Health Condition 1: R652- Severe sepsis Health Condition 2: P039- Newborn affected by complication of labor and delivery, unspecified
Conditions
Interventions
Intervention1: Intervention group (Selective antibiotic group): Each centre will administer antibiotics according to its own empiric antibiotic policy. These policies are based upon local antibiotic s
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gestational age 26 to 34 weeks, 2. Chronological age 4 hours, 3. Have any one or both of the following risk factors of EONS (prolonged rupture of membranes greater than 18 hours, or prelabour rupture of membranes), 4. Are either asymptomatic or have no signs attributable to sepsis at 4 hours. This will be defined as absence of the following clinical signs or need for interventions mentioned below a. Apnea requiring intervention at any time until enrolment, b. Need for a fluid bolus or inotrope support at any time until enrolment, c. Seizures or seizure like activity at any time until enrolment, d. Upper GI bleed in the absence of a history of antepartum hemorrhage at any time until enrolment, e. Pus from any site at any time until enrolment, f. Need for CPAP greater than 6 cm of water with FiO2 greater than 35% at 4 hours or need for CPAP less than or equal to 6 cm and FiO2 less than or equal to 35% but with increasing requirement of support, g. Chest x-ray if performed with radiological features of pneumonia, h. Need for intubation and mechanical ventilation, i. Temperature greater than 37.5°C or less than 36°C unexplained by environmental causes, j. Feed intolerance [bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or greater than 50% of the previous feed volume is gastric residuals], k. Lethargy or unarousability, l. Sclerema
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they have any one of the following 1. Life-threatening congenital malformation, 2. Severe perinatal asphyxia (Apgar score less than 5 at 10 minutes or cord pH less than 7), 3. Clinical chorioamnionitis, 4. Foul-smelling liquor, 5. Multiple gestation, 6. Received a dose of antibiotics, 7. Positive amniotic fluid culture (if performed and result available prior to randomization), 6. Treating neonatologists unwilling to enrol the patient in the trial on the grounds that the patient needs antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be a composite of any episode of severe sepsis OR any episode of culture positive sepsis OR all cause mortality. Severe sepsis will be defined as Clinical signs of sepsis AND Either a positive blood culture or laboratory evidence of sepsis (either CRP OR Procalcitonin above the age appropriate cut off value OR any two of the CBC parameters outside the age appropriate ranges OR chest x ray suggestive of pneumonia) AND One or more of the following indices of severity (Need for intubation and mechanical ventilation, Need for inotropes dopamine or dobutamine equal to or greater than 10 microgram per kg per minute or adrenaline equal to or greater than 0.05 microgram per kg per minute, Need for exchange transfusion, Need for platelet concentrates or FFP, Meningitis defined as either CSF culture positive or Gram stain positive or Cell count 25 per microlitre or glucose 25 mg per dl or protein 180 mg per dl).Timepoint: 0 to 7 days of life | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause MortalityTimepoint: 0-7 days of life ;Blood culture positive sepsis of any severityTimepoint: 0-7 days of life;Episode of severe sepsisTimepoint: 0-7 days of life;Co-primary outcome: need for course of intravenous antibiotics for greater than or equal to 48 hoursTimepoint: 0 to 7 days of life;Composite of all-cause mortality OR blood culture positive sepsis OR severe sepsisTimepoint: 0 to 72 hours of life;All cause mortality within 72 hoursTimepoint: 0 to 72 hours of life;Blood culture positive sepsis within 72 hoursTimepoint: 0 to 72 hours of life;Episode of severe sepsis within 72 hoursTimepoint: 0 to 72 hours of life;Composite of all cause mortality or blood culture positive sepsis or severe sepsisTimepoint: Hospital stay;All cause mortality during hospital stayTimepoint: Hospital stay;Blood culture positive sepsis during hospital stayTimepoint: Hospital stay;Severe sepsis during hospital stayTimepoint: Hospital stay;NEC stage 2 or 3Timepoint: Hospital stay;Composite of all-cause mortality or blood culture positive sepsis or severe sepsis during 1st 30 days of lifeTimepoint: 0 to 30 days of life;All cause mortality during 1st 30 days of lifeTimepoint: 0 to 30 days of life;Blood culture positive sepsis during 1st 30 days of lifeTimepoint: 0 to 30 days of life;Severe sepsis during 1st 30 days of lifeTimepoint: 0 to 30 days of life;NEC stage 2 or 3 during 1st 30 days of lifeTimepoint: 0 to 30 days of life;Sepsis related mortality within 72 hoursTimepoint: 0 to 72 hours of life;Sepsis related mortality within 7 days of lifeTimepoint: 0 to 7 days of life;Sepsis related mortality during hospital stayTimepoint: Hospital stay;Sepsis related mortality during 1st 30 days of lifeTimepoint: 0 to 30 days of life;Episode of clinical sepsis within 72 hoursTimepoint: 0 to 72 hours of life;Episode of clinical sepsis within 7 daysTimepoint: 0 to 7 days of life;Episode of clinical sepsis during hospital stayTimepoint: Hospital stay;Episode of clinical sepsis during 1st | — |
Countries
India
Contacts
Public ContactSourabh Dutta
Post Graduate Institute of Medical Education and Research
Outcome results
None listed