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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  
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 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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aritraray.sunny1988@gmail.com].

  6. 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.

  7. 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,


 
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