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

Not Applicable

Completed

• Conditions: Health Condition 1: P789- Perinatal digestive system disorder, unspecified

• Registration Number: CTRI/2020/03/023728
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-15
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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