Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-26
Brief Title:
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sponsor:
Indian Council of Medical Research
Organization:
Indian Council of Medical Research
Study Overview
Official Title:
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates At-risk of Early-onset Bacterial Sepsis a Multicentric Randomized Controlled Non-inferiority Trial the SAUNA Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAUNA
Brief 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
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
Detailed Description:
Sepsis is the major cause of neonatal mortality and early-onset neonatal sepsis EONS accounts for more than two-thirds of all cases of neonatal sepsis Prolonged rupture of membranes PROM and preterm premature rupture of membranes pPROM are important risk factors of EONS There is equipoise in the published literature whether antibiotics must be immediately initiated among all preterm neonates 35 weeks gestation delivered following PROM or pPROM who are asymptomatic at birth or whether antibiotics can be selectively administered if and when the at-risk neonates become symptomatic
Among neonates 35 weeks gestation born with PROM 18 hours or pPROM and who are either asymptomatic or have no symptoms of sepsis at 4 hrs postnatally P is selectively administering antibiotics to neonates who later develop clinical sepsis I compared to administering antibiotics pre-emptively to all at-risk neonates C non-inferior with respect to the composite outcome of mortality andor culture-positive sepsis andor severe sepsis O within 7 days after enrolment T by an absolute margin of 7 E in a randomized controlled trial S The trial will also have a superiority outcome need for antibiotic treatment lasting greater than 48 hours within 7 days after enrolment The absolute superiority margin will be 50
The main objectives are as follows
1 To determine whether antibiotics administered selectively to at-risk preterm neonates 35 weeks gestation with prolonged rupture of membranes PROM or preterm premature rupture of membranes pPROM when they develop signs of sepsis compared to administering antibiotics from birth to all at-risk neonates is non-inferior with respect to the primary outcome of mortality or any episode of culture-positive sepsis or severe sepsis in the 1st week of life
2 To determine whether neonates receiving selective antibiotics as above compared to those receiving antibiotics from birth as above are superior with respect to the co-primary outcome of fewer antibiotic courses of 48 hours duration or more in the 1st week of life
3 To determine whether neonates 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
Among neonates 35 weeks gestation born with PROM 18 hours or pPROM and who are either asymptomatic or have no symptoms of sepsis at 4 hrs postnatally P is selectively administering antibiotics to neonates who later develop clinical sepsis I compared to administering antibiotics pre-emptively to all at-risk neonates C non-inferior with respect to the composite outcome of mortality andor culture-positive sepsis andor severe sepsis O within 7 days after enrolment T by an absolute margin of 7 E in a randomized controlled trial S The trial will also have a superiority outcome need for antibiotic treatment lasting greater than 48 hours within 7 days after enrolment The absolute superiority margin will be 50
The main objectives are as follows
1 To determine whether antibiotics administered selectively to at-risk preterm neonates 35 weeks gestation with prolonged rupture of membranes PROM or preterm premature rupture of membranes pPROM when they develop signs of sepsis compared to administering antibiotics from birth to all at-risk neonates is non-inferior with respect to the primary outcome of mortality or any episode of culture-positive sepsis or severe sepsis in the 1st week of life
2 To determine whether neonates receiving selective antibiotics as above compared to those receiving antibiotics from birth as above are superior with respect to the co-primary outcome of fewer antibiotic courses of 48 hours duration or more in the 1st week of life
3 To determine whether neonates 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None