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Comparison of Expressed (pumped out) Breast Milk and 10% Dextrose when given orally in reducing intensity of pain in newborns before painful procedures (like heel prick) done as a part of newborn care.

To compare the effect of Expressed Breast Milk (EBM) vs 10% Dextrose in reducing procedural pain in term neonates- A Randomized Control Trial in a Rural teaching hospital in Telangana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034053
Enrollment
60
Registered
2021-06-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: 10% Dextrose: 2ml of 10% Dextrose given orally via paladay Control Intervention1: Expressed Breast Milk (EBM): 2ml of Expressed BM orally via paladay

Sponsors

Dr Dasari Sandhya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term Healthy Neonates(Babies who have completed 37 weeks gestational age) requiring heel prick procedure for monitoring hypoglycemia like Low birth weight babies(LBW),Infants of Diabetic mothers(IDM) done routinely as a part of newborn care protocol

Exclusion criteria

Exclusion criteria: 1) Neonates who require resuscitation at birth, 2) Neonates on Life support like CPAP/oxygen/ Ventilator 3) Neonates with congenital anomalies pertaining to head and face - cleft lip and palate 4) Sick neonates-sepsis, neonatal seizure 5) Preterm babies( 42 completed weeks) 6) Neonates whose parents refuse to consent for the study

Design outcomes

Primary

MeasureTime frame
To compare the effect of Expressed breast milk (EBM) vs 10% Dextrose over intensity of pain in term neonates using NIPS scale (Neonatal Infant Pain Scale)Timepoint: NIPS (Neonatal infant pain scale) score would be assigned to the neonate before the heel prick procedure and at 30 secs, 2 mins and 4 mins after the procedure and documented by observer 2.—

Secondary

MeasureTime frame
1.To assess and compare the duration of cry in term neonates following the use of EBM and 10% Dextrose 2.To compare the changes in physiological variables like Heart Rate, SpO2 between both groups after the painful procedure; following administration of EBM or 10% Dextrose. Timepoint: The observer 1 will document the duration of the cry and record changes in heart rate and SPO2 at 30 secs, 2 mins and 4 mins after the procedure—

Countries

India

Contacts

Public ContactPreethi Subramanian

Mediciti Institute of Medical Sciences

sandhyadasari@gmail.com7989502749

Outcome results

None listed

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