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

Efficacy Of Expressed Breast Milk In reducing pain during routine Screening Procedure in Pre Term Neonates-A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017180
Enrollment
60
Registered
2019-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: B998- Other infectious disease

Interventions

Intervention1: Expressed Breast Milk plus standard care: 5ml of EBM will be given to respective child before 5 mins of procedure according to code revealed from SNOSE along with standard care.After 5m

Sponsors

Dr samar pratim nayak
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime 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).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

MeasureTime frame
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).

Countries

India

Contacts

Public ContactDr samar pratim Nayak

MAZUMDAR SHAW MEDICAL CENTER NARAYANA HEALTH CITY BANGALORE

Harini.sreedaran.dr@narayanahealth.org09880706620

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026