| CTRI Number |
CTRI/2022/09/045682 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Timing of introduction of complementary feed] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Timing of introduction of complementary feed in preterm infants |
|
Scientific Title of Study
|
Timing of introduction of complementary feed in infants born pretermin a tertiary care NICU follow up clinic- 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 |
ARITRA RAY |
| Designation |
Senior Resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department-Neonatology
Division -NN ward
room no 219,
New Delhi
DELHI
110001
India Central DELHI 110001 India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sushma Nangia |
| Designation |
Director Professor and Head |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
Lady Hardinge Medical College,
Department -Neonatology
JICA building
room no -335
New Delhi
DELHI
110001 Central DELHI 110001 India |
| Phone |
9810838181 |
| Fax |
|
| Email |
drsnangia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sushma Nangia |
| Designation |
Director Professor and Head |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
Lady Hardinge Medical College,
Department -Neonatology
JICA building
room no -335
New Delhi
DELHI
110001 Central DELHI 110001 India |
| Phone |
9810838181 |
| Fax |
|
| Email |
drsnangia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dept of Neonatology |
| Address |
Lady Hardinge Medical College New Delhi |
| 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 Sushma Nangia |
Lady Hardinge Medical College |
Room no 219 ,KSCH 2nd floor
High risk follow up clinic Dept of Neonatology, Lady Hardinge Medical College,New Delhi
New Delhi
DELHI Central DELHI |
9810838181
drsnangia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Human research Lady Hardinge Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Introduction of complementary feed at 6 months chronological age |
Babies born between 26-34 wks are follow up in High risk clinic & complementary feeding started at 6 months chronological age |
| Intervention |
Introduction of complementary feed at 6 months corrected age |
Babies born between 26-34 wks are follow up in High risk clinic & complementary feeding started at 6 months corrected age |
|
|
Inclusion Criteria
|
| Age From |
6.50 Month(s) |
| Age To |
8.50 Month(s) |
| Gender |
Both |
| Details |
Preterm of neonatology neonates (Gestational age 26-34weeks of completed gestation) Discharged from Department Lady Hardinge Medical College & KSCH & SSKH
being followed up Follow up in High risk clinic at 6 months of chronological age.
|
|
| ExclusionCriteria |
| Details |
- Infants with major congenital anomalies or syndromes.
- Infants who remains to be admitted beyond 44 weeks corrected age in Department of neonatology
- Infants who develops surgical NEC or major GI surgery
- Infants having severe neurological deficit at discharge
- Parents staying outside the Delhi.NCR region
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effects of timing of introduction of complementary feeding on anthropometry. |
at 6 months after starting of complementary feed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality rate & Duration of hospital stay |
at 3 & 6 months after starting of complementary feed |
| Recurrence of infection requiring hospitalization |
at 3 & 6 months after starting of complementary feed. |
| Iron status (MCV.MCH,MCHC ,hb,hct) |
at the starting of complementary feeding & 6 months after starting of complementary feeding |
| Calcium homeostasis |
at the starting of complementary feeding & 6 months of starting of complementary feeding |
| BP |
at 6 months of starting of complementary feeding |
| Neurodevelopment |
at 6 months of starting of complementary feeding
|
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="91" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2022 |
| Date of Study Completion (India) |
10/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aritraray.sunny1988@gmail.com].
- For how long will this data be available start date provided 10-12-2022 and end date provided 06-10-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Hypothesis -Infants
born preterm started on complementary feeding at 6 months corrected age have better
outcome in terms of growth when compared
to initiation of complementary feeding at 6 months chronological age . Consent- Parents or legally acceptable
representative (LAR) of newborns meeting eligibility criteria will approached
for informed consent. An information sheet providing the details of the study
will be provided to the parents/LAR Parents are free not to participate, or to
withdraw their child from the study at any point of time and no coercion will
be involved. Enrollment-Babies born between 26-34
wks are discharged from department of neonatology ,these neonates discharged
from our hospital will be asked to follow up in High risk clinic .At 6 months
of chronological age the baby would be enrolled & randomisation into group A (Introduction of
complementary feed at 6 months corrected age)or
group B(Introduction of
complementary feed at 6 months chronological age) is done . IYCF
counselling at enrolment will be done in
all neonates in our study. All
twins & triplets to be enrolled in same group. Primary objective: To
compare the
effects of introduction of complementary feeding in 6 months corrected age vs 6
months chronological age in anthropometry. a) Weight
for age (grams) b) Lt
for age, (cm) c) Weight
for Length, d) HC
for age,(cm) e) MUAC
including z scores, f) triceps
skin fold thickness (mm) Secondary objectives: 1. Mortality
rate, & Duration of hospital stay at
3
month & 6 month of starting of complementary feeding . 2. Recurrence
of infection requiring additional hospitalization, at 3 month & 6 month of starting of
complementary feed. 3. Iron
status, at the starting of complementary feeding & 6 months of starting of
complementary feeding 4. Calcium
homeostasis (ca+2,po 4 ,alkaline phosphatase ),at the starting of
complementary feeding & 6 months of
starting of complementary feeding. 5. Hormonal
assay (leptin ,cortisol ),at 6 months of starting of complementary feeding. 6.
BP at 6 months of
starting of complementary feeding
7. Neurodevelopment at 6 months of starting of complementary
feeding,
|