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Blood flow in brain and feeling of pain while putting feeding tubes in small babies

Cortical hemodynamic activity and pain perception during insertion of feeding tubes in preterm neonates: A randomized controlled cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023728
Enrollment
100
Registered
2020-03-03
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: P789- Perinatal digestive system disorder, unspecified

Interventions

Intervention1: Nasogastric placement of feeding tube: Nasogastric feeding tube will be placed in spontaneously breathing early preterm neonates (â?¤34 weeksâ?? gestation) not requiring any respiratory

Sponsors

All India Institute of Medical Sciences Rishikesh India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Spontaneously breathing early preterm neonates (<=34 weeksâ?? gestation) not requiring any respiratory support, not accepting direct breastfeeding/cup feeding and dependent on tube feeding for enteral nutrition

Exclusion criteria

Exclusion criteria: 1. Neonates with congenital malformations including cleft lip or palate 2. Neonates on respiratory support or sedation 3. Neonates with encephalopathy, intraventricular hemorrhage grade three or more, shock, patent ductus arteriosus 4. Failure to obtain consent from parents

Design outcomes

Primary

MeasureTime frame
To evaluate the effects of the route of feeding tube insertion (orogastric vs nasogastric) on the cortical hemodynamic activity using near infrared spectroscopy (NIRS) and pain scores using premature infant pain profile (PIPP).Timepoint: Primary outcome will be assessed at the time of insertion of naso/orogastric feeding tube.

Secondary

MeasureTime frame
1. Heart rate variability 2. Change in perfusion index (PI) 3. Oxygen saturation (SpO2) variability 4. Duration of cry Timepoint: Secondary outcomes will be assessed at the time of insertion of naso/orogastric feeding tube.

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

drjayaupadhyay12@gmail.com9424779769

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 22, 2026