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CTRI Number  CTRI/2023/11/060366 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 25/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [POSITIONING]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effectiveness of two different positions during tube feeding on physiological parameters, pain and stress and feeding tolerance of preterm neonates.-RCT 
Scientific Title of Study   The effect of the ESL and the ESU position on physiological parameters, pain and stress and feeding tolerance of preterm neonates during Oro-gastric tube feeding in an NICU of tertiary care hospital - A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayantika Chandra 
Designation  M. Sc Nursing Student 
Affiliation  AIIMS BHUBANESWAR 
Address  COLLEGE OF NURSING, AIIMS BHUBANESWAR, SIJUA PATRAPADA,PO-DUMUDUMA,ODISHA

Khordha
ORISSA
751019
India 
Phone  6291335485  
Fax    
Email  ayantikachandra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Asha P Shetty 
Designation  Prodessor-cum-Principal 
Affiliation  AIIMS BHUBANESWAR 
Address  COLLEGE OF NURSING, AIIMS BHUBANESWAR, SIJUA PATRAPADA,PO-DUMUDUMA,ODISHA

Khordha
ORISSA
751019
India 
Phone  9448770302  
Fax    
Email  nurs_asha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Asha P Shetty 
Designation  Professor cum Principal 
Affiliation  AIIMS BHUBANESWAR 
Address  COLLEGE OF NURSING, AIIMS BHUBANESWAR, SIJUA PATRAPADA,PO-DUMUDUMA,ODISHA

Khordha
ORISSA
751019
India 
Phone  9448770302  
Fax    
Email  nurs_asha@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
NA All India Institute of Medical Sciences(AIIMS) Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  COLLEGE OF NURSING, AIIMS BHUBANESWAR, SIJUA, PATRAPADA, PO-DUMUDUMA, ODISHA 751019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tapas Som  NICU, AIIMS BHUBANESWAR  AIIMS BHUBANESWAR, SIJUA, PATRAPADA, PO-DUMUDUMA, ODISHA, 751019
Khordha
ORISSA 		 6291335485

ayantikachandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ESL (semielevated side lying)  In this study the semielevated side lying position refer to the position, in which their head and trunk will be elevated to an angle of 30-45o with the help of a pillow as in the breast-feeding position where the one ear will be facing the ceiling and the other ear facing the pillow. Their knees and hip will be leaned against the researchers arms and their head and neck will be held at the same level by the researcher; whereas, their chin will be held in the flexion posture mildly facing the chest. 
Comparator Agent  ESU (semielevated supine)  In this study semielevated supine position refers to the supine position given to the baby where, their head and trunk were elevated to an angle of 30-45o with the help of pillow where the head and neck will be held at the same level by the researcher, whereas their chin will be held in the flexion posture mildly pointing to the chest. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  2.00 Month(s)
Gender  Both 
Details  Preterm infants who were born at <34 gestational weeks, stable vital signs, orogastric tube feeding, and has parental consent. 
 
ExclusionCriteria 
Details  Preterm infants with necrotizing enterocolitis history, respiratory distress, congenital anomalies, neurological and cardiological problems and use of medication that may affect pain and stress levels such as analgesics, sedatives and muscle relaxants. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain and stress of preterm neonate during OG Tube feeding.  Before, during and 1st,5th,15th,30th and 60th minute after feeding 
 
Secondary Outcome  
Outcome  TimePoints 
Stabilisation of physiological parameters during tube feeding.  Before, during & 1st,5th,15th,30th & 60th minute after feeding 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   05/12/2028 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Prior permission obtained from the Principal, College of Nursing.

 Permission will be taken from Head of the department of Neonataolgy

 Ethical approval obtained from Institute Ethics Committee, AIIMS, Bhubaneswar.

 Precautions for patient safety and the reduction of environmental stimuli will be taken before Tube Feeding. Measures will be taken to ensure patient safety include checking the enteral tube placement before Tube feeding. Feeding will be done slowly by gravity.

All preterm infants will be checked for the eligibility criteria and then data will be collected.

 The form for infant descriptive characteristics will be filled for each infant before the feeding.

The pain and stress levels of the infants will be evaluated 2 mins before Tube feeding. Subsequently, the infants’ RR, HR, SpO2 levels, AC will be measured in the supine position and recorded.

  The infant will then be randomised to AB OR BA Sequence. (A = semi-elevated right lateral position, B = semi-elevated supine position)

 The infant will then be placed in the identified position and Tube Feeding commenced. The stress and pain levels of the infants will be assessed during Tube Feeding, and physiological changes will be measured during Tube Feeding. Infant feeding times will be measured and recorded.

 After completion of feeding readings were taken in 1st, 5th, 15th,30th and 60th minutes.

 In the next feeding the infant will be positioned in the alternate position and all the process will be repeated.

 Positioning supports will be used for both positions. Also, in NICU, where the study is carried out, the feeding tubes remain indwelling in the baby.

 
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