The property Of Expressed Breast Milk In reducing pain during routine Screeing painful Procedure in Pre mature newborn-A Randomised Control Trial

Completed

Conditions: Medical and Surgical, (2) ICD-10 Condition: B998||Other infectious disease,

Registration Number: CTRI/2019/01/017180

Lead Sponsor: Dr samar pratim nayak

Brief Summary: Efficacy of expressed breast milk in reducing pain during routine screening procedure in pre term neonates-a randomised controlled trial

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

All preterm/premature neonates inborn and admitted in NICU / IPD/ well baby,(<37wks,<2500gms) had APGAR scores â©¾7 at 5 minutes; were aged â©¾24 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).	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)	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).

Trial Locations

Locations (1): DEPARTMENT OF PEDIATRICS
🇮🇳
Bangalore, KARNATAKA, India
DEPARTMENT OF PEDIATRICS
🇮🇳Bangalore, KARNATAKA, India
Dr SAMAR PRATIM NAYAK
Principal investigator
9938058020
samardream@gmail.com