se of probiotics in sick premature infants
Not Applicable
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2021/03/031724
- Lead Sponsor
- Surya Mother and child superspeciality hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Infants with birth weight <1500 g [very low birth weight infants (VLBW)] who are started on enteral feeds.
2.Gestational age < 32 weeks
3.Hemodynamically stable
Exclusion Criteria
1.Infants who have gastrointestinal anomalies
2.Severe birth asphyxia (defined as APGAR score <3 at 5 minutes)
3.Cyanotic congenital heart disease
4.Those not started on feeds by 14 day of life
5.Gestational age > 32 weeks
6.Hemodynamically unstable
7.Congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes will be composite outcome of sepsis (blood culture positive sepsis) or NEC Stage II (modified bell staging) or mortality.Timepoint: duration of NICU stay
- Secondary Outcome Measures
Name Time Method sepsis, NEC Stage II or above, all-cause mortality, feed intolerance episodes defined as above, time to reach full feeds, duration of TPN, duration of hospital stay, growth velocity.Timepoint: duration of NICU stay