A study to assess appropriate method of feeding in preterm neonates during blood transfusion

Optimal Feeding Strategy during Blood Transfusion in Preterm Neonates: A Randomized Controlled Trial - FiT-Neo

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084784

Enrollment

102

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: P612- Anemia of prematurity

Interventions

Intervention1: Feeds continued: The trial compares continued feeding against nil per oral (NPO) during blood transfusion among preterm neonates. So, in the intervention arm the feeding pattern (type,

Eligibility

Inclusion criteria

Inclusion criteria: All haemodynamically stable neonates with gestational age less than 35 weeks requiring PRBC transfusion and tolerating oral feeds

Exclusion criteria

Exclusion criteria: Major congenital anomalies Confirmed NEC before enrolment IVH grade III or more Cutaneous disease that prevents probe placement

Design outcomes

Primary

Measure	Time frame
Splanchnic cerebral oxygenation ratio at the end of transfusionTimepoint: 4 hours after starting transfusion	—

Secondary

Measure	Time frame
A. Splanchnic oxygenation parameters 1.SrSO2- both overall between two arms and pre- and post-transfusion 2.CrSO2 3.Splanchnic FOE B. Superior mesenteric artery Doppler parameters 1.Peak systolic velocity 2.End diastolic velocity 3.Time average mean velocity 4.Pulsatility index 5.Resistive index C. Clinical parameters 1.Incidence of TANEC and NEC 2.Incidence of feed intolerance within 48h of transfusion 3.Incidence of ROP, BPD and IVH 4.Time to full feeds 5.Length of stay 6.MortalityTimepoint: During hospital stay and until discharge or death, whichever is earlier	—

Measure

Time frame

A. Splanchnic oxygenation parameters 1.SrSO2- both overall between two arms and pre- and post-transfusion 2.CrSO2 3.Splanchnic FOE B. Superior mesenteric artery Doppler parameters 1.Peak systolic velocity 2.End diastolic velocity 3.Time average mean velocity 4.Pulsatility index 5.Resistive index C. Clinical parameters 1.Incidence of TANEC and NEC 2.Incidence of feed intolerance within 48h of transfusion 3.Incidence of ROP, BPD and IVH 4.Time to full feeds 5.Length of stay 6.MortalityTimepoint: During hospital stay and until discharge or death, whichever is earlier

—

Countries

India

Contacts

Public ContactShikhar Garg

All India Institue of Medical Sciences, Rishikesh

shikhargarg45@gmail.com8800918714

Outcome results

None listed

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