Selective antibiotics when symptoms develop versus universal antibiotics for preterm neonates

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 randomized trial compares a selective antibiotics strategy to a universal antibiotics approach in preterm infants with prolonged rupture of membranes or preterm premature rupture of membranes. Eligible neonates are born before 35 weeks, are 4 hours old, asymptomatic for sepsis, and have specific ROM/pPROM risk factors. The study will look at the composite outcome of all-cause mortality, culture-positive sepsis, and severe sepsis within 7 days, with non-inferiority defined by an absolute risk difference of 7%, plus a superiority component focused on mortality or excessive IV antibiotic exposure. The trial is sponsored by the Indian Council of Medical Research with several collaborating centers in India. If successful, the approach could reduce unnecessary antibiotic exposure while maintaining safety for vulnerable newborns.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Gestational age of 26 0/7 to 34 6/7 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 4 hours OR need for CPAP less than or equal to 6 cms and FiO2 less than or equal to 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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Where it's running

• Government medical College Chandigarh
  Chandigarh, Chandigarh, India Recruiting
• Post Graduate Institute of Medical Education and Research (PGIMER)
  Chandigarh, Chandigarh, India Recruiting
• Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
  Rohtak, Haryana, India Recruiting
• IGICH bengaluru
  Bengaluru, Karnataka, India Recruiting
• Government Medical College, Aurangabad
  Chhatrapati Sambhajinagar, Maharashtra, India Recruiting
• King Edward Memorial Hospital
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Sourabh Dutta, MD, Ph.D — Post Graduate Institute of Medical Education and Research, Chandigarh
• Study coordinator: Sourabh Dutta, MD, Ph.D
• Email: sourabhdutta1@gmail.com
• Phone: +91-1722755313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.