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CTRI Number  CTRI/2024/07/069780 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 29/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Re-feeding versus discarding stomach aspirates and its effect on time to reach full feeds in preterm infants 37 weeks gestation 
Scientific Title of Study   Re-feeding versus discarding gastric residuals in preterm infants less than 37 weeks of gestation - a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology, Seth G. S. Medical College, Parel, Mumbai - 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology, Seth G. S. Medical College, Parel, Mumbai - 400012


MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anitha Haribalakrishna 
Designation  Associate Professor and Head of Department 
Affiliation  Seth G.S. Medical College & KEM Hospital 
Address  Department of Neonatology, Seth G. S. Medical College, Parel, Mumbai - 400012


MAHARASHTRA
400012
India 
Phone  9769660870  
Fax    
Email  ani.gem81@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, New building, 10th floor, Seth GS Medical College and KEM Hospital, Mumbai 400058 
 
Primary Sponsor  
Name  KEM hospital 
Address  Acharya Donde Marg, Parel, Mumbai 400012 
Type of Sponsor  Government medical college 
 
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 Anitha Haribalakrishna  Seth GS Medical College and KEM Hospital  New building 10th floor ward 38 Department of Neonatology KEM hospital, Mumbai 400058
Mumbai
MAHARASHTRA 
9769660870

ani.gem81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee III relating to biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fresh feeding group  Gastric residual volume will be discarded even if it is curdy or light green in colour and fresh feeding with mother’s own expressed breast milk (MOM) will be done.This will be followed till discharge from NICU 
Intervention  Refeeding gastric residues group  Gastric residual volumes will be checked with a syringe prior to each feeding, with the infant in the supine position. In the presence of gastric residues irrespective of the amount, gastric residual volumes will be re-fed. Curdy, light green or dark yellow aspirate will be fed back. This will be followed till discharge from NICU 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  any preterm infant less than 37 weeks of gestation will be included after obtaining written informed consent from the parents. 
 
ExclusionCriteria 
Details  Any preterm with congenital anomalies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to attain full enteral feeds (120ml/kg/day)  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Time to regain birth weight (in days)  4 weeks 
Rate of weight gain (g/kg/d), linear growth (cm/week), and increase in head
circumference (cm/week) during the initial hospitalization period 
4 weeks,8 weeks 
Risk of necrotizing enterocolitis (NEC) stage ≥ 2 (modified Bell’s staging) or
spontaneous intestinal perforation (SIP) 
4 weeks 
Duration of hospital stay  8 weeks 
Number of days receiving total par enteral nutrition (TPN)  4 weeks 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 4 
Date of First Enrollment (India)   01/08/2024 
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="1"
Months="0"
Days="0" 
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  

Early achievement of full enteral feeds in preterm infants has shown improved growth, and neurodevelopment and reduced the rate of sepsis. Gastric residual volumes are essential for digestion and gastrointestinal tract motility and maturation. Disposing of the partially digested milk and replacing it with fresh milk for the neonate might heighten the strain on the immature gut of preterm infants, consequently raising the likelihood of feed intolerance. It may create potentially creating an alkaline environment that increases the risk of NEC and late-onset sepsis. Conversely, reintroducing bile-stained or bloodstained gastric residuals during feeding may cause gastric irritation and vomiting and heighten the risk of infection, potentially resulting in NEC, sepsis, or both, when handling and reintroducing gastric contents. It usually depends on the nature and amount of the gastric aspirates. Available data from trials suggests that there is considerable variability in the approach to either refeeding or discarding gastric residual. Studies in neonates are limited. Given the lack of enough evidences from clinical trials, we aim to compare whether re-feeding of gastric residual volumes would reduce the time needed to achieve full enteral feeding in preterm infants and to determine whether the rate of death, duration of hospital stay, occurrence of NEC or feed intolerance would differ between the two groups.

 
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