Effectiveness of Oral Immunotherapy Among Preterm Babies

Effectiveness of Mother's Own Colostrum and Breast Milk as Oral Immunotherapy and on the Feeding Behaviors and Clinical Outcome Among Preterm Infants

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

Study Overview

• Status: Completed
• Conditions: Feeding Behavior; Late-Onset Neonatal Sepsis
• Intervention / Treatment: Other: Sterile water; Biological: Breastmilk

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Shiney Easo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sterile water; Sterile water: Started by six hours of age, In the control arm, 0.2 ml of sterile water is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The liquid is given time to get absorbed, any pooled liquid is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours.	Other: Sterile water; Placebo Comparator: Sterile water: 0.2 ml of sterile water is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The liquid is given time to get absorbed, any pooled liquid is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours.; Other Names: Placebo
Experimental: Breastmilk; Breastmilk. This is started at 6 hours of age at the earliest; breast milk: 0.2 ml of mothers' own colostrum/ breast milk is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The colostrum is given time to get absorbed, any pooled milk is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours.	Biological: Breastmilk; Experimental: Breastmilk: 0.2 ml of mothers' own colostrum/ breast milk is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The colostrum is given time to get absorbed, any pooled milk is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours. independently sucks at breast, bottle or cup feed; Other Names: experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Behaviors	feeding behaviour is assessed using a questionaire on feeding behaviour. it consist of feed interruptions due to intolerance, time to reach full enteral feeding, time to independent oral feeds via direct breastfeed, cup or syringe feed or bottle feed consistently for 48 hours safely.	Birth to 45 weeks post menstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late onset sepsis	late onset sepsis is measured using questionnaire on clinical outcome . it consist of culture proven sepsis and number of episodes.	Birth to 45 weeks post menstrual age

Collaborators and Investigators

• Sponsor: Al Adan Hospital Kuwait
• Investigators: Principal Investigator: Shiney Easo, masters, AL Adan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Sepsis; Preterm; Oral feeding; Colostrum; Oral immune therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis
• Other Study ID Numbers: 545/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No