ROLE OF ORAL APPLICATION OF COLOSTRUM IN IMPROVEMENT OF HEALTH IN PRETERM INFANTS

Not yet recruiting

• Conditions: Preterm infants born between 26 - 30 wks period of gestation, Morbidity and mortality associated with prematurity

• Registration Number: CTRI/2017/03/008031
• Lead Sponsor: SUDEEP K C

Brief Summary

Despiteadvances in neonatal medicine, preterm and very low birth weight(VLBW)  infants have substantial mortality andmorbidity, often resulting from late-onset neonatal sepsis (LONS) andnecrotizing enterocolitis (NEC). This is attributed to a large extent tothe  immature immune system in theseinfants which predisposes them to increased risk of infection associatedmorbidity and mortality.

Preterm infants are functionally immunodeficient, have immature intestinal mucosal barrier, require multiple invasive lines andprocedures as part of their care. In addition to these, long term exposure topathogens in neonatal intensive care unit(NICU) , overuse of antibiotics,delayed initiation of enteral feeds, presence of  gastric tubes and  multiple intravenous lines are factors thatpredispose VLBW infants to increased risks of sepsis and other co-morbiditieslike NEC, intraventricular hemorrhage  (IVH)etc. During breastfeeding or oral feeding of breast milk, the lymphoid cells inthe oral mucosa get stimulated which leads to development of oral mucosaassociated lymphoid tissue. The development of acquired immunity viabreastfeeding and oral feeding has proven role in prevention of infectionassociated morbidity like LONS and NEC. Colostrum is the milk produced duringthe first few days after birth. It contains various substances that provideimmunity in high concentration, to newborn babies. Even small volume of colostrums contains increased concentrationsof secretory immunoglobulin A (sIgA), growth factors, lactoferrin,anti-inflammatory cytokines, pro inflammatory cytokines, and other protectivecomponents, compared with mature breast milk.  Mother’smilk contains many biofactors which are immunomodulatory in nature. Lactoferrin,one of many biofactors contained in mother’s milk, can protect against LONS andNEC via various mechanisms. Clinical instability and  immaturity precludes enteral feeds forextremely premature infants in the first days of life. Even when started, ininfants with gestation less than 31weeks, enteral feeds have to be  given  via a gastric tube because of undeveloped orpoorly developed coordination of swallowing, breathing and sucking. This bypassesthe infant’s oropharynx and therefore, the infant’s oropharynx is not exposedto protective (immune and trophic) milk biofactors until oral feeds areintroduced several days later. To overcomethis handicap of the immature infant, oral application of colostrum andmother’s own milk has been tried in very low birth weight infants and shown tobe safe and feasible. It has been shown to improve  the concentrations of several immunesubstances in the urine, saliva and tracheal secretions as well as decrease thelevels of inflammatory substances like Interleukin-10. Oral application ofcolostrum has also shown benefits in achieving full feeds earlier anddecreasing the duration of parenteral nutrition. we plan to conduct arandomized controlled trial  of oralapplication of colostrum  and placebo tostudy the effects on above listed clinical outcomes in preterm infants of 26 to30 weeks gestation.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Last Update Posted: 2017-06-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Inborn infants with gestation of 26 to 30weeks admitted under neonatology unit.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse health outcome	The outcome will be assessed at time of death , discharge or transfer to another hospital.
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 Measures

Name	Time	Method
Mortality	Prior to discharge from hospital
Definite sepsis	Probable sepsis
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
Bronchopulmonary dysplasia	Till death, discharge or transfer to another hospital
Necrotising Enterocolitis	Till death , discharge or transfer to another hospital

Trial Locations

Locations (1)

PGIMER Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sudeep K C

Principal investigator

9501782481

sudeepkecy2011@gmail.com