Necrotizing Enterocolitis Clinical Trial
Official title:
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates. Multi-centre, Randomised, Double-blind, Placebo-controlled Clinical Study.
Verified date | February 2014 |
Source | IBSS Biomed S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ethics Committee |
Study type | Interventional |
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its
influence on emergence and development of natural intestinal flora and the clinical status
of premature very low birth weight neonates. The study was also intended to investigate
reduction of colonisation by pathogenic bacteria and to estimate the incidence of
gastrointestinal disorders.
Probotic bacteria contained in the investigational product administered directly after birth
are beneficial for the development of normal gut microflora and can prevent or significantly
limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic
flora in a hospital setting. Permanent colonisation with commensal flora in very early life
improves gastrointestinal function in premature neonates by reducing the onset of or by
decreasing the severity of the signs and symptoms of feeding intolerance and generalised
bacterial infections, including sepsis and necrotizing enterocolitis.
Status | Completed |
Enrollment | 182 |
Est. completion date | December 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 48 Hours |
Eligibility |
Inclusion Criteria: 1. Infants = 750 g and = 1800 g at birth 2. Gestational age of = 34 weeks 3. Mother's age = 18 years 4. Possibility of feeding by enteral route 5. Possibility of enrolment = 48 hours of age 6. Caucasian race 7. Parent-legal guardian informed consent obtained in writing Exclusion Criteria: 1. Infants < 750 g and > 1800 g at birth 2. Gestational age of > 34 weeks 3. Mother's age < 18 years 4. Contraindicated to enteral nutrition within the first 48 hours of life 5. Birth asphyxia (Apgar score: 0-3) 6. Major congenital abnormalities, including gastrointestinal abnormalities 7. Severe clinical condition / disorders which the Investigator considers a contraindication to study participation, including the presence of at least 3 out of 4 of the following symptoms: 1. necessity of mechanical ventilation and FiO2 more than 0.6 elevation to maintain blood oxygen saturation within 88-93%, 2. metabolic acidosis, pH less than 7.20 and BE more than (-10), 3. necessity of vasopressor (antihypotensive) agents to maintain proper arterial blood pressure, 4. signs of damage to at least one vital organ (liver, kidneys, gastrointestinal tract, adrenal glands). 8. Administration of other probiotic preparations 9. Enrolment in any other clinical trial throughout the study period 10. Lack of parent-legal guardian informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
IBSS Biomed S.A. | Ministry of Science and Higher Education, Poland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal tract colonisation | Bacteriological tests involved quantitative and qualitative assessment of neonatal gut flora during clinical follow-up. Bacterial populations of Lactobacillus and Bifidobacterium as well as pathogenic bacteria were assesed. Stool samples were collected at 7-day intervals (±2 days) in the period of investigational product intake, and on Day 7 (±2 days) after the last dose of the investigational product. |
Assesed on days 1, 7, 14, 21, 28, 35, 42 and 49 (assesed weekly within eight weeks) | Yes |
Primary | Feeding intolerance episodes (including: gastric residuals, vomiting, regurgitation of food, abdominal distension, abdominal rigidity, gut motility disorders) | Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Primary | Incidence and type of adverse events and serious adverse events with special regard to sepsis caused by bacteria contained in investigational product. | Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo with special regard to sepsis caused by bacteria contained in investigational product . | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Late onset sepsis caused by Gram positive or Gram negative bacteria | Sepsis was confirmed by positive blood cultures. Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Gastrointestinal perforation | Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Duration of total parenteral nutrition (days) | Duration of total parenteral nutrition (hyperalimentation) was evaluated until full enteral nutrition is restored. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Duration (days) of absence of enteral nutrition due to gastrointestinal disorders | Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Duration (days) of absence of enteral nutrition for reasons other than gastrointestinal disorders | Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Weight, length and head circumference | Weight, length and head circumference were evaluated throughout the period of care according to standard neonatal care procedures. | Weight was measured once daily, head circumference was measured once a week, and body length was measured on Day 1 and on Day 7 (±2 days) from the last dose (or until the patient was discharged or withdrawn from the study) | Yes |
Secondary | NEC - intensity and severity | Severity of neonatal necrotizing enterocolitis was determined according Bell's criteria. Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Mortality rate, with a focus on deaths attributed to NEC and sepsis | Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
Secondary | Duration of hospitalization (days) (until discharge) | Duration of hospitalization was investigated from the date of patient enrolment until discharge. | Assesed on a daily basis (from 1 to 42 and on day 49) | Yes |
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