Effect of warm fluid injection in babies with low blood pressure

Physiological changes after warm fluid bolus therapy in neonates with shock: A Pilot Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070286

Enrollment

Registered

2024-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: Warm fluid bolus therapy: Neonates in this group will receive warm normal saline 10 mL/kg over 20 minutes using fluid warmer set at 37 degree Celsius temperature Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with shock as defined by ACCM guidelines

Exclusion criteria

Exclusion criteria: 1.Major congenital anomaly 2.Moderate to severe hypoxic ischemic encephalopathy till first 72 hours of life 3.Congenital heart disease 4.Already on inotropes 5.Fever 6.Post-operative patients developing shock in the first 24 hours of surgery 7.Signs of fluid over load

Design outcomes

Primary

Measure	Time frame
Mean core body temperature in the warm vs room temperature fluid bolus at the end of therapyTimepoint: 20 minutes	—

Secondary

Measure	Time frame
1.Mean peripheral temperature and other vital parameters at the end of therapy and 30 minutes after completion of fluid bolus therapy 2.Changes in vital parameters before and after fluid bolus therapy 3.Incidence of hypo or hyperthermia 4.Rate of resolution of hypotension 5. Proportion of neonates requiring inotropes 6. Final outcome Timepoint: Before discharge	—

Countries

India

Contacts

Public ContactDr Manish Chaudhary

All India Institute of Medical Sciences, Rishikesh

drpoonamujn@gmail.com857106059

Outcome results

None listed

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