Effectiveness of Oral Immunotherapy Among Preterm Babies

NCT03633500 | Completed

• 1 other identifier: 545/2017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Feeding Behavior; Late-Onset Neonatal Sepsis

Keywords

Colostrum; Oral immune therapy; Preterm; Oral feeding; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Late onset sepsis

  Birth to 45 weeks post menstrual age

Study Arms (2)

Sterile water

PLACEBO COMPARATOR

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

Breastmilk

EXPERIMENTAL

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

Interventions

Sterile water OTHER

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.

Also known as: Placebo

Sterile water

Breastmilk BIOLOGICAL

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

Also known as: experimental

Breastmilk

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm babies below 33 weeks (32+6) weeks of gestation
• Birth weight \<1500 g

You may not qualify if:

• 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

Sponsors & Collaborators

• Al Adan Hospital Kuwait: lead

Study Sites (1)

Shiney Easo

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

Feeding Behavior; Neonatal Sepsis; Premature Birth; Sepsis

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Shiney Easo, masters

  AL Adan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Block size and number of blocks: the sample size estimated for the study was 48 the size of the blocks is fixed in nature. Hence there are 6 blocks with a block size of 8 preterm babies each in every block. Allocation ratio: one to one allocation ratio will be used for the study. Since the block size is 8 and one to one allocation was used, each block consist of 4 babies in each group (experimental:4, control =4) Sequence generation: 6 sets of random sequence will be generated with the help of research randomizer, an online random number generator. The sequence will be generated by an external member, who was not directly involved in the study. Allocation concealment: Concealed allocation was achieved using sequentially Numbered, Opaque, Sealed Envelopes (SNOSESs). SNOSESs were prepared by an external member, who was not a part of study and kept in an opaque envelope. Blinding: is done by covering the syringe with adhesive silk tape.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Nurse,

Model Details: the intervention is carried out among preterm babies below 33 weeks of gestation or weight less than 1500gm

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: August 16, 2018
• Study Start: August 16, 2018
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)