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CTRI Number  CTRI/2017/03/008031 [Registered on: 07/03/2017] Trial Registered Prospectively
Last Modified On: 06/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   ROLE OF ORAL APPLICATION OF COLOSTRUM IN IMPROVEMENT OF HEALTH IN PRETERM INFANTS 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL OF ORAL APPLICATION OF COLOSTRUM TO IMPROVE HEALTH OUTCOMES IN PRETERM INFANTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudeep KC 
Designation  Junior Resident 
Affiliation  Department of Pediatrics, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)  
Address  NICU office, Neonatal Division, Department of Pediatrics, Nehru Hospital, Level 3,PGIMER, Sec-12, Chandigarh, India
Room no D54, Old Doctors Hostel, PGIMER , Sec 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9501782481  
Fax    
Email  sudeepkecy2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praveen Kumar 
Designation  Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)  
Address  NICU office, Neonatal Division, Department of Pediatrics, Nehru Hospital, Level 3,PGIMER, Sec-12, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008302  
Fax    
Email  drpkumarpgi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Praveen Kumar 
Designation  Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)  
Address  NICU office, Neonatal Division, Department of Pediatrics, Nehru Hospital, Level 3,PGIMER, Sec-12, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087008302  
Fax    
Email  drpkumarpgi@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  SUDEEP K C 
Address  NICU office, Neonatal Division, Department of Pediatrics, Nehru Hospital, Level 3,PGIMER, Sec-12, Chandigarh, India 
Type of Sponsor  Research institution and hospital 
 
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 Sudeep K C  PGIMER Chandigarh  Neonatal unit, Department of Pediatrics, Nehru Hospital, Level 3,PGIMER, Sec-12, Chandigarh, India
Chandigarh
CHANDIGARH 
9501782481

sudeepkecy2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Preterm infants born between 26 - 30 wks period of gestation, Morbidity and mortality associated with prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colostrum  Colostrum obtained from mother in first few days of life 
Comparator Agent  Sterile water  Commercially available distilled sterile water  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  1. Inborn infants with gestation of 26 to 30weeks admitted under neonatology unit 
 
ExclusionCriteria 
Details  1. Parents not willing to give consent
2. Babies born with major life threatening congenital malformations
3.Babies born with severe birth asphyxia
4. If breast milk feeding is contraindicated
5. Triplets and higher birth orders
6. Infants already enrolled in any other research/ study that can
influence our study outcomes
4.5.vii Colostrum is unavailable at the time of enrolment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Adverse health outcome
Adverse health outcome will be a composite of occurrence of any one of the following : (a) death during hospital stay, (b) culture positive or probable sepsis, (c) necrotizing enterocolitis stage 2 , (d) bronchopulmonary dysplasia , (e) intraventricular hemorrhage grade 2, (f) retinopathy of prematurity needing treatment
 
The outcome will be assessed at time of death , discharge or transfer to another hospital. 
 
Secondary Outcome  
Outcome  TimePoints 
Mortality  Prior to discharge from hospital 
Definite sepsis
Probable sepsis 
Till death, discharge or transfer to another hospital 
Necrotising Enterocolitis  Till death , discharge or transfer to another hospital 
Bronchopulmonary dysplasia  Till death, discharge or transfer to another hospital 
Intraventricular Hemorrhage  Till death, discharge or transfer to another hospital 
Retinopathy of prematurity  Till death, discharge or transfer to another hospital 
Time to full feed  Till death, discharge or transfer to another hospital 
Days on antibiotics  Till death, discharge or transfer to another hospital 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   15/03/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Despite advances in neonatal medicine, preterm and very low birth weight(VLBW)  infants have substantial mortality and morbidity, often resulting from late-onset neonatal sepsis (LONS) and necrotizing enterocolitis (NEC). This is attributed to a large extent to the  immature immune system in these infants which predisposes them to increased risk of infection associated morbidity and mortality.

Preterm  infants are functionally immunodeficient , have immature intestinal mucosal barrier, require multiple invasive lines and procedures as part of their care. In addition to these, long term exposure to pathogens in neonatal intensive care unit(NICU) , overuse of antibiotics, delayed initiation of enteral feeds, presence of  gastric tubes and  multiple intravenous lines are factors that predispose VLBW infants to increased risks of sepsis and other co-morbidities like NEC, intraventricular hemorrhage  (IVH) etc. During breastfeeding or oral feeding of breast milk, the lymphoid cells in the oral mucosa get stimulated which leads to development of oral mucosa associated lymphoid tissue. The development of acquired immunity via breastfeeding and oral feeding has proven role in prevention of infection associated morbidity like LONS and NEC. Colostrum is the milk produced during the first few days after birth. It contains various substances that provide immunity in high concentration, to newborn babies. Even small volume of colostrums contains increased concentrations of secretory immunoglobulin A (sIgA), growth factors, lactoferrin, anti-inflammatory cytokines, pro inflammatory cytokines, and other protective components, compared with mature breast milk.  Mother’s milk contains many biofactors which are immunomodulatory in nature. Lactoferrin, one of many biofactors contained in mother’s milk, can protect against LONS and NEC via various mechanisms. Clinical instability and  immaturity precludes enteral feeds for extremely premature infants in the first days of life. Even when started, in infants with gestation less than 31weeks, enteral feeds have to be  given  via a gastric tube because of undeveloped or poorly developed coordination of swallowing, breathing and sucking. This bypasses the infant’s oropharynx and therefore, the infant’s oropharynx is not exposed to protective (immune and trophic) milk biofactors until oral feeds are introduced several days later. To overcome this handicap of the immature infant, oral application of colostrum and mother’s own milk has been tried in very low birth weight infants and shown to be safe and feasible. It has been shown to improve  the concentrations of several immune substances in the urine, saliva and tracheal secretions as well as decrease the levels of inflammatory substances like Interleukin-10. Oral application of colostrum has also shown benefits in achieving full feeds earlier and decreasing the duration of parenteral nutrition. we plan to conduct a randomized controlled trial  of oral application of colostrum  and placebo to study the effects on above listed clinical outcomes in preterm infants of 26 to 30 weeks gestation.

 

 
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