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A randomized control trial on comparing tube feeding during Kangaroo Mother Care versus lying down in supine position to assess feed intolerance in preterm and Low Birth Weight newborns having birth weight less than 1500 g

Efficacy of gavage feeding in KMC position Vs supine position in preterm and low-Birth-weight newborns (less then 1500 g) In reducing feed intolerance: A randomized Control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100571
Enrollment
150
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P788- Other specified perinatal digestive system disorders

Interventions

Intervention1: Gavage feeding in KMC (Kangaroo Mother Care) position: Infants will receive slow Gavage feeding via syringe Pump over 1 h while in a semi-Upright, prone KMC position on The caregiver s

Sponsors

Shree Krishna Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm (Gestational age less then 37 weeks) and Low-Birth-Weight Newborns (Birth weight less then 1500 grams) eligible For KMC (Kangaroo Mother Care) And requiring gavage feeding will be Enrolled.

Exclusion criteria

Exclusion criteria: 1-Major congenital anomalies or genetic disorder 2-Birth asphyxia (Apgar less then 5 at 10 minutes Or blood Gas pH less then 7 or base excess more Then -16) 3-Intraventricular Haemorrhage Grade II or More (Volpe) 4-Hypotension requiring inotropes 5-Abnormal fetal Doppler indices. 6-NEC Stage II or more (Modified Bell s Criteria)

Design outcomes

Primary

MeasureTime frame
To compare the incidence of Feeding intolerance (defined By any of this: prefeed Gastric Residual Volume more Then 50 percents, abdominal Distension more then 2 cm, Regurgitation or vomiting, Occult or overt blood in Stool), between the two Groups.Timepoint: Data will be collected until The infant starts accepting Oral feeding by spoon or Direct breastfeeding—

Secondary

MeasureTime frame
1-Number of Nil Per Mouth (NPO) days. 2-Episodes of bradycardia (Pulse Rate less then 100 / Min), desaturation (SPO2 less Then 85%), thermoregulation And other significant events. 3-To assess weight gain and length of hospital stay. 4-To compare total daily KMC Hours between groups. 5-To evaluate feasibility and Acceptability of GF KMC among Nurses and mothers.Timepoint: Data will be collected until The infant starts accepting Oral feeding by spoon or Direct breastfeeding—

Countries

India

Contacts

Public ContactDipen Vasudev Patel

Shree Krishna Hospital, Pramukhswami Medical College, Bhaikaka University, Karamsad, District- Anand

smitshethwala@gmail.com7574870554

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026