| CTRI Number |
CTRI/2024/07/069958 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Post discharge fortification of human milk |
|
Scientific Title of Study
|
Clinical outcomes related to human milk fortification in very low birth weight preterm infants post discharge- a prospective observational study |
| Trial Acronym |
NIL |
|
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 |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology,New building, 10th floor, King Edward Memorial Hospital
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anitha Haribalakrishna |
| Designation |
Associate Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology,New building, 10th floor, King Edward Memorial Hospital
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anitha Haribalakrishna |
| Designation |
Associate Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology,New building, 10th floor, King Edward Memorial Hospital
Mumbai (Suburban)
MAHARASHTRA
400058
India |
| Phone |
09769660870 |
| Fax |
|
| Email |
ani.gem81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital, Acharya Donde Marg, parel, Mumbai, India, 400012 |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Neonatology
KEM Hospital, New building, 10th floor, Parel, Mumbai, 400012
Mumbai |
| 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 |
| Anitha Haribalakrishna |
Seth GS Medical College and KEM Hospital |
New building 10th floor ward 38 Department of Neonatology
KEM hospital
Mumbai
MAHARASHTRA |
09769660870
ani.gem81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II relating to biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O602||Term delivery with preterm labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group
|
HMF was stopped at discharge and infants were discharged on calcium, iron and vitamin D supplementation according to their weight till they reach one year of age. |
| Intervention |
Post discharge fortification group |
where HMF was continued post discharge till infant reached 1.8 Kg which will be 4 to 6 weeks after dischrge |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Inborn neonates ≤ 37 completed weeks of gestation with birth weight < 1.5 Kg who were on
either mother’s own milk (MOM) or pasteurized donor human milk (PDHM) supplemented
with bovine derived human milk fortifier (HMF) were enrolled in the study within 24 hours
of life. |
|
| ExclusionCriteria |
| Details |
Preterm infants who were not compliant with HMF, infants with severe intraventricular hemorrhage (IVH), post hemorrhagic ventricular dilatation (PHVD), meningitis, and poor neurological outcomes at discharge were excluded. We also excluded surgical infants and those with congenital anomalies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gain in weight per day |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gain in length |
28 days |
| gain in head circumference |
28 days |
| incidence of NEC as per Bell’s stage ≥II |
28 days |
| feed intolerance |
28 days |
| late onset sepsis |
28 days |
| mortality |
28 days |
| anaemia of prematurity (AOP), |
28 days |
| retinopathy of prematurity (ROP) |
28 days |
| osteopenia of prematurity (OOP) |
28 days |
| bronchopulmonary dysplasia (BPD) |
28 days |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Months="6"
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
|
Advancements in medical care over the past two decades has led to an
improved survival of preterm infants globally. However, these preterm
infants especially very low birth weight (VLBW) infants are at a higher risk of
growth faltering during their neonatal intensive care unit (NICU) stay and
infancy post discharge. Supplementation of expressed breast milk with a multi-nutrient
bovine-based human milk fortifier (HMF) to meet these additional nutritional
needs in preterm VLBW infants is currently the standard practice worldwide.Infants are
discharged on full oral feeds along with iron, calcium and Vitamin D
supplementation. These preterm infants are followed up in the preterm follow up
centre and are at high risk of growth faltering due to early stoppage of HMF at discharge. . Hence, we decided to study the feasibility and effects of continuing HMF till
these infants reach postnatal weight of 1800 gram or PMA of 40 weeks which was
feasible only as post discharge fortification.Neonates meeting the
inclusion criteria were allotted in one of the two groups two days prior to
discharge: 1) intervention group where HMF was continued post discharge till infant
reached 1.8 Kg 2) control group: HMF
was stopped at discharge and infants were discharged on calcium, iron and
vitamin D supplementation according to their weight.
|