Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, 110001, India
NCT Number: NCT06197269
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.
Looking for future studies?
Notify Me28 week–36 week
All sexes
Interventional
Not applicable
New Delhi, National Capital Territory of Delhi, 110001, India
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)
Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics
Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(All must be present)
Exclusion criteria
antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment
Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.
Time frame: 15 days of stopping antibiotics
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
Time frame: Till 1 month of life
Death due to any reason
Time frame: Till 1 month of life
Additional courses during the study time frame
Time frame: From date of birth until date of death or discharge whichever come assessed till 1 month of life
Duration of hospital stay
Lady Hardinge Medical College
Other Gov
Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03997266
Communicable Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Mobile, Alabama, United States
View Trial DetailsNCT05329701
Antibiotic Side Effect, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Copenhagen, Denmark
View Trial DetailsNCT03694613
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Early-Onset Neonatal Sepsis
Galveston, Texas, United States
View Trial DetailsNCT06100614
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Early-Onset Neonatal Sepsis
Amsterdam, North Holland, Netherlands
View Trial Details