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CTRI Number  CTRI/2024/10/075115 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Immunomodulatory Effect of Oropharyngeal Administration of Colostrum]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Oropharyngeal Administration of Colostrum in Premature Neonates 
Scientific Title of Study   Immunomodulatory Effect of Oropharyngeal Administration of Mother Colostrum in Preterm Neonates 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha Kumari 
Designation  Postgraduate student  
Affiliation  University College of Medical Sciences and GTB Hospital  
Address  Department of Paediatrics, GTB Hospital, Dilshad Garden, Delhi

East
DELHI
110095
India 
Phone  8826074857  
Fax    
Email  dr.meghasah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Sachan 
Designation  Associate Professor  
Affiliation  University College of Medical Sciences and GTB Hospital  
Address  Department of Paediatrics, GTB Hospital, Dilshad Garden, Delhi

East
DELHI
110095
India 
Phone  7839100100  
Fax    
Email  drravisachangtbh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha Kumari 
Designation  Postgraduate student  
Affiliation  University College of Medical Sciences and GTB Hospital  
Address  Department of Paediatrics, GTB Hospital, Dilshad Garden, Delhi

East
DELHI
110095
India 
Phone  8826074857  
Fax    
Email  dr.meghasah@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences & GTB Hospital, Dilshad Garden, Delhi  
 
Primary Sponsor  
Name  Intramural Research Grant, University College of Medical Sciences  
Address  UCMS and GTB Hospital, Dilshad Garden, Delhi - 110095 
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 Megha Kumari   University College of Medical Sciences and GTB Hospital   MCH building, 6th floor, Department of Paediatrics, GTB Hospital, Dilshad Garden, Delhi - 110095
East
DELHI 		 8826074857

dr.meghasah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Human Research, University College of Medical Sciences, University of Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R768||Other specified abnormal immunological findings in serum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mother’s colostrum   Oropharyngeal administration of mother’s colostrum, 0.2 ml, 4 hourly, for 5 days 
Comparator Agent  Nil per oral preterm neonates  Nothing to be administered  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Preterm neonates with 30-34 weeks of gestational age, admitted in the NICU 
 
ExclusionCriteria 
Details  1. Neonates on enteral feeding
2. Neonates who received blood transfusions during the study period
3. Major congenital anomalies
4. Neonates born to HIV positive or Hepatitis B positive or Hepatitis C positive mothers
5. Neonates born to mothers who are on any antipsychotics or chemotherapeutic agents
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The mean concentrations of serum IgA in both groups (the colostrum group and the control group)  On day 1 and day 5 
 
Secondary Outcome  
Outcome  TimePoints 
1. The mean concentrations of serum immunoglobulins (IgG and IgM) and serum inflammatory markers (IL-6 and TNF alpha) in both groups.
2. The proportion of feed intolerance and necrotizing enterocolitis in both groups.  		 On day 1 and day 5 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   N/A 
Date of First Enrollment (India)   15/10/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Title: Immunomodulatory Effect of Oropharyngeal Administration of Mother’s Colostrum In Preterm Neonates.


Rationale: Due to an immature gastrointestinal tract and comorbidities preventing enteral feedings, delivering colostrum to preterm infants through the enteral route is challenging. Oropharyngeal administration of colostrum emerges as a potential option.


Objectives:

Primary objective: To compare the mean concentrations of serum immunoglobulin A (IgA) following oropharyngeal administration of mother’s colostrum against a control group during the first 5 days of life in preterm neonates with gestational age between 30-34 weeks.

Secondary Objectives:

1. To compare the mean concentrations of serum immunoglobulins (IgG and IgM) and serum inflammatory markers (IL-6, TNF alpha) in both groups.

2. To compare the proportion of feed intolerance and necrotizing enterocolitis in both groups.


Study Design: Open label randomized controlled trial.


Study Duration: April 2024 to August 2025 (17 months duration).


Participants: 

Inclusion Criteria : Preterm neonates with 30-34 weeks of gestational

age, admitted in the NICU.

Exclusion criteria:

1. Neonates on enteral feeding.

2. Neonates who received blood transfusions during the study period.

3. Major congenital anomalies.

4. Neonates born to HIV positive or Hepatitis B positive or Hepatitis C positive mothers.

5. Neonates born to mothers who are on any antipsychotics or chemotherapeutic agents.


Procedures : Oropharyngeal administration of 0.2 ml of colostrum will occur every 4 hours for 5 days, starting within 24 hours after birth. Blood samples will be collected on day 1 and day 5.


Outcome Measures :

Primary Outcome: The mean concentrations of serum IgA in both groups.

Secondary Outcomes:

1. The mean concentrations of serum immunoglobulins (lgG. IgM) and serum inflammatory

markers (IL-6 & TNF alpha) in both groups.

2. The proportion of feed intolerance and necrotizing enterocolitis in both groups.


Sample Size: 76 Preterm neonates divided into : the colostrum group and the control group.


Statistical Analysis: Quantitative variables will be described as mean (SD)/median (IQR). Between-group and within-group comparisons of mean will be conducted through unpaired t-test and paired t-test respectively. For comparing medians, Mann Whitney U test will be used. For comparing qualitative variables Chi square test will be used. P value <0.05 will be considered as significant.

 
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