Health Condition 1: null- NEONATES WITH BIRTH WEIGHT GREATER THAN 1500 GRAMS WITH BLOOD CULTURE SHOWING GRAM NEGATIVE BACTERIA
Conditions
Interventions
Intervention1: DURATION OF ANTIBIOTIC THERAPY: Infants in both the groups that is short duration and long duration will receive similar care in the NICU except for duration of antibiotics therapy.
Sho
Sponsors
NONE
Eligibility
Inclusion criteria
Inclusion criteria: Neonates with gestational with birth weight > 1500 g, who satisfy all the following criteria will be enrolled: i.Clinical signs of sepsis as per NEOKISS criteria present before antibiotic therapy (Appendix I) in addition to other signs ii.Blood culture showing growth of a pathogenic GNB iii.Repeat blood culture after 7 days of sensitive antibiotic therapy should be sterile iv.Infant should be in remission defined as being on full feeds, not on mechanical ventilation (except high flow nasal cannulae) or on inotropes.
Exclusion criteria
Exclusion criteria: The following patients will be excluded: 1.Infants born with major congenital malformations such as diaphragmatic hermia, abdominal wall defects, neural tube defects, esophageal atresia with/without fistula etc. 2.Severe birth asphyxia (defined as APGAR score 3.Infants being planned to be treated for neonatal meningitis as per attending neonatologist [ ]. 4.Those undergoing or underwent major surgeries. 5.Infants with clinically evident bone (osteomyelitis) / joint (arthritis) [1]. 6.Infants whose blood cultures were interpreted as â??contaminant or possible contaminantâ??. 7.Refusal of consent or unlikely to follow up for 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary 1.Treatment failur defined as positive blood culture for same organism within 28 days of antibiotic completion therapy.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 1.Duration of hospital stay in days. 2.Complications of IV therapy such as extravasation injuries/phlebitis/hematoma. 3.Duration of mechanical ventilation/inotropic support/TPN.4.Need for blood products 5.Episodes of new onset sepsis (blood culture positive) by a different organism. 6.All cause mortality within 4 weeks of completion of antibiotic therapy.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactAnurag Fursule
SIR GANGARAM HOSPITAL,NEW DELHI
Outcome results
None listed