Effectiveness of Oral Immunotherapy Among Preterm Babies

Sponsor

Al Adan Hospital Kuwait (Industry)

Overall Status

Completed

CT.gov ID

NCT03633500

Collaborator

(none)

Enrollment

Location

Arms

4.4

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Feeding Behavior Late-Onset Neonatal Sepsis	Other: Sterile water Biological: Breastmilk	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 16, 2018

Actual Primary Completion Date :

Dec 28, 2018

Actual Study Completion Date :

Dec 28, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feeding Behaviors [Birth to 45 weeks post menstrual age]
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.

Secondary Outcome Measures

Late onset sepsis [Birth to 45 weeks post menstrual age]
late onset sepsis is measured using questionnaire on clinical outcome . it consist of culture proven sepsis and number of episodes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiney Easo	Kuwait		Kuwait

Sponsors and Collaborators

Al Adan Hospital Kuwait

Investigators

Principal Investigator: Shiney Easo, masters, AL Adan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shiney Easo, Staff Nurse,, Al Adan Hospital Kuwait

ClinicalTrials.gov Identifier:

NCT03633500

Other Study ID Numbers:

545/2017

First Posted:

Aug 16, 2018

Last Update Posted:

Jul 12, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shiney Easo, Staff Nurse,, Al Adan Hospital Kuwait

Additional relevant MeSH terms:

Neonatal Sepsis

Study Results

No Results Posted as of Jul 12, 2019