Clinical trial NCT03633500: Effectiveness of Oral Immunotherapy Among Preterm Babies
Official title: Effectiveness of Mother's Own Colostrum and Breast Milk as Oral Immunotherapy and on the Feeding Behaviors and Clinical Outcome Among Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Late-Onset Neonatal Sepsis
Keywords: Colostrum
Oral immune therapy
Preterm
Oral feeding
Sepsis
Lead sponsor: Al Adan Hospital Kuwait
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 48
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the intervention is carried out among preterm babies below 33 weeks of gestation or weight less than 1500gm
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feeding Behaviors
timeFrame: Birth to 45 weeks post menstrual age
Secondary outcomes:
measure: Late onset sepsis
timeFrame: Birth to 45 weeks post menstrual age
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Shiney Easo
Study officials:
affiliation: AL Adan Hospital
name: Shiney Easo, masters
role: PRINCIPAL_INVESTIGATOR
References: