| 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
|
|
|
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
|
|
|
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. |