The property Of Expressed Breast Milk In reducing pain during routine Screeing painful Procedure in Pre mature newborn-A Randomised Control Trial
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: B998- Other infectious disease
- Registration Number
- CTRI/2019/01/017180
- Lead Sponsor
- Dr samar pratim nayak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
All preterm/premature neonates inborn and admitted in NICU / IPD/ well baby,( <37wks, <2500gms) had APGAR scores ⩾7 at 5 minutes; were aged ⩾24 hours; were undergoing venepuncture
Exclusion Criteria
â?ªAll term neonates
â?ªDiagnosed with neurologic problems of any type, if they had received analgesic or sedative drugs within 24 hours of enrolment or neonates having cardio-respiratory compromise, sepsis, central nervous system depression and severe congenital malformations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow).Timepoint: The primary outcome is pain intensity as assessed with the PIPP. The score is assessed at baseline (before starting the procedure),during the procedure and at 1 min and 3 min after the procedure. The PIPP scale is a multidimensional measure developed to assess acute pain in preterm and term infants. It measures gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, nasolabial furrow).
- Secondary Outcome Measures
Name Time Method Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia)Timepoint: Secondary outcomes included crying incidence, percentage of time spent crying during and 3 minutes after lancing, and the incidence of AEs (Eg, nausea, regurgitation, vomiting, choking, de-saturation, tachycardia and bradycardia).