SepsisPROM, Preterm (Pregnancy)Early-Onset Neonatal SepsisPreterm Premature Rupture of MembranePreterm Birth
Investigational drug(s) / intervention(s)
Antibiotics
Antibiotics: In experimental arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered selectively to those newborn infants who later develop clinical signs of sepsis according to a predefined repertory of clinical signs.
In active comparator arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered pre-emptively to all newborn infants from enrollment even if they do not have any clinical signs of sepsis at enrollment
Study summary
Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.
The goal of this research study is to find out:
1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.
2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.
3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes").
Eligibility
Sex
ALL
Min age
0 Hours
Max age
4 Hours
Healthy volunteers
No
Inclusion criteria:
* Gestational age of 26 to 34 weeks
* Chronological age 4 hours
* Have any one or both of the following risk factors of EONS:
* Prolonged rupture of membranes \>18 hours
* Pre-labour rupture of membranes \[as all subjects will be preterm, this is effectively pPROM\]
* 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:
1. Apnea (Standard definition) requiring intervention at any time until enrolment.
2. Need for a fluid bolus or inotropic support at any time until enrolment.
3. Seizures or seizure-like activity at any time until enrolment.
4. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment.
5. Pus from any site at any time until enrolment.
6. Need for CPAP \>6 cms of water with FiO2 \>35% at 6-8 hours OR need for CPAP £6 cms and FiO2 £35% but with increasing requirement of support\*\*
7. Chest Xray (if performed) with radiological features of pneumonia.
8. Need for intubation and mechanical ventilation.
9. Temperature \>37.5°C or \<36°C, unexplained by environmental causes
10. Feed intolerance \[bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or \>50% of the previous feed volume as gastric residuals\]
11. Lethargy or unarousability
12. Sclerema
Exclusion Criteria:
Subjects will be excluded if they have any 1 of the following:
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1. Life-threatening congenital malformation
2. Severe perinatal asphyxia (Apgar score \<5 at 10 minutes or cord pH \<7.0)
3. Clinical chorioamnionitis# \[see definition below\]
4. Foul-smelling liquor
5. Multiple gestation
6. Received a dose of antibiotics
7. Positive amniotic fluid culture (if performed and available prior to randomization)
8. Treating neonatologist unwilling to enroll the patient in the trial on the grounds that the patient needs antibiotics.
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Primary outcome measure(s)
Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization — Within 1st 7 days after randomization Either mortality due to any cause and/or an episode of culture-positive sepsis and/or severe sepsis. These outcomes will be measured within the "1st 7 days after randomization", which for all practical purposes, is equivalent to the "1st 7 days of life" since participants will be randomized at about 4 hours of life. Hence, the duration expressed after randomization and of life will be used interchangeably for this outcome and other outcomes.
Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization — Within 1st 7 days after randomization Requirement for intravenous antibiotic courses whose duration is ≥ 48 hours with the onset of the course within the first 7 days after randomization. For all practical purposes, this would be equivalent to the 1st 7 days of life since participants will be randomized at about 4 hours of life.
Trial sites (1)
Facility
City
Region
Status
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh
India
More Indian Council of Medical Research trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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