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
|
|
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
|
|
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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