Effectiveness of Oral Immunotherapy Among Preterm Babies
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding
 behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
A randomized placebo-controlled double-blinded study in preterm infants < 32+6 weeks'
 gestation or Birth weight < 1500 g who are admitted to NICU.

 Exclusion criteria include infants with congenital anomalies, out born infants, infants of
 single mothers with unknown partners (mother is separated from preterm infants based on the
 state law) and infants admitted beyond 48 hours of age, confirmed immunodeficiency disorder,
 Inborn Error of Metabolism, parental refusal to participate. The infants who have overt
 bleeding, thrombocytopenia < 50,000/mm3 or are critically ill requiring multiple inotropes in
 high doses, on High frequency ventilation and inhaled nitric oxide and infants with
 congenital surgical abdomen are excluded from the study.

 An informed parental consent is obtained at the initial post-natal visit. Each neonate is
 then randomly assigned to the placebo or intervention group per the block randomization
 generated using a computer-generated allocation sequence. Allocation is concealed from all
 involved investigators, bedside nurses, doctors, parents and outcome assessors except the
 International Board Certified Lactation Consultant (IBCLC) assigned to allocate the
 intervention. The IBCLC is not an investigator in the study.

 Intervention group:

 Colostrum that is fresh or refrigerated is collected by the IBCLC and prepared using 1cc
 syringes which are labeled with patient identification data, date and time of milk
 expression. These syringes are concealed using adhesive silk tapes and handed over to the
 bedside nurse. The tip of the syringe is placed towards the posterior end of the buccal
 cavity, colostrum/breastmilk is slowly squirted in aliquots of 0.1 ml of the milk into the
 area . This is to be done slowly drop by drop over a 30 s period. The milk should not pool in
 the buccal cavity. If it pools, give a few seconds to get absorbed and the rest may be
 manually rubbed using a swab along the gums and the inner surface of the buccal cavity for 10
 seconds with two strokes in each area. Repeat the procedure on the opposite side. If the
 colostrum was refrigerated the syringe may be kept in the warm incubator for five minutes
 before administering.

 OIT will be initiated as soon after birth as colostrum is available no earlier than six hours
 of age and continued every 4 hours as available. OIT may be provided in babies who are kept
 nil per oral and is to be continued even when enteral feeding has been ordered to get a
 minimum of 20 doses and can be continued until the baby reaches full oral feeding.

 Control group: The control group will receive 0.2 ml of sterile water that will be prepared
 and applied in an identical manner and frequency to that among the intervention group. This
 will be started at six hours of age to avoid disclosure of intervention and control group.
 However, as soon as Mother's milk is available it will be initiated enterally.
Inclusion Criteria:

 -  Preterm babies below 33 weeks (32+6) weeks of gestation

 -  Birth weight <1500 g

 Exclusion Criteria:

 -  Preterm babies with congenital anomalies

 -  Preterm babies with congenital infection like pneumonia.

 -  Babies born in other hospitals

 -  Babies of single mothers with unknown partners

 -  Confirmed immunodeficiency disorder,

 -  Inborn Error of Metabolism,

 -  Parental refusal to participate.

 -  Preterm babies who have overt bleeding