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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
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 4 Months|
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Al Adan Hospital Kuwait|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Shiney Easo, masters|
|Principal Investigator Affiliation||AL Adan Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Feeding Behavior, Late-Onset Neonatal Sepsis|
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.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Shiney Easo, masters
For additional contact information, you can also visit the trial on clinicaltrials.gov.