Efficacy Of Expressed Breast Milk In reducing pain during routine Screening Procedure in Pre Term Neonates-A Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
Brief Summary
Efficacy of expressed breast milk in reducing pain during routine screening procedure in pre term neonates-a randomised controlled trial
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Day(s) to 6.00 Day(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
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).
Time Frame: 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 Outcomes
- 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)(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).)