None listed
Conditions
Brief summary
This research is about finding the optimal dosage of probiotics for sick newborn babies with gestational age greater or equal to 35 weeks, admitted to Neonatal Intensive Care Unit (NICU) of Perth Children’s Hospital. Their sickness could have been either due to a medical illness or a surgical condition. We will find out if a dose higher than 3 billion probiotic bacteria per day reduces the load of harmful bacteria and increases the load of beneficial bacteria in their gut. We will measure the gut bacteria by examining their stool (poo) samples using sophisticated laboratory investigations. Specifically, we will compare the dose of 3 billion bacteria against doses of either 6 or 9 billion bacteria per day. We think that babies who receive higher dose of probiotics will have better intestinal bacteria profile and better overall health.
Interventions
Probiotic mixture containing B. breve M-16V, B. longum subsp. infantis M-63, and B. longum subsp. longum BB536 (3x109 CFU per sachet), manufactured and supplied by Morinaga Milk Industries, Japan)
Study infants will receive different dosage regimen of probiotic supplement as described below:
3 billion Colony-Forming Unit (CFU) daily (ONE sachet once a day)
6 billion CFU daily (ONE sachet twice a day)
9 billion CFU daily (ONE sachet three times a day)
Duration: until discharge from NICU
Route:
Probiotic mixture containing B. breve M-16V, B. longum subsp. infantis M-63, and B. longum subsp. longum BB536 (3x109 CFU per sachet), manufactured and supplied by Morinaga Milk Industries, Japan) Study infants will receive different dosage regimen of probiotic supplement as described below: 3 billion Colony-Forming Unit (CFU) daily (ONE sachet once a day) 6 billion CFU daily (ONE sachet twice a day) 9 billion CFU daily (ONE sachet three times a day) Duration: until discharge from NICU Route: oral or via feeding tube. Each Sachet (3x109 CFU per sachet) will be reconstituted with 1.5mL of water or breast milk or formula milk and then given once or twice or three times a day. The oral route of administration will be achieved by drawing the reconstituted trial supplement in a two ml syringe and administered immediately into the infant's mouth. we will assess adherence to the intervention by filling out an accountability record in addition to the review of medical records.
Sponsors
Child and Adolescent health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 4 Weeks
Healthy volunteers
No
Inclusion criteria
Infants will be eligible for study inclusion it they meet both the following inclusion criteria: >=35 weeks of gestational age with critical illness AND informed parental consent. The infant should meet at least one of the following criteria to be deemed having critical illness: • Need for mechanical ventilation • Use of inotropic agents • Persistent pulmonary hypertension of the newborn (PPHN), requiring inhaled nitric oxide or other pulmonary vasodilators • Moderate to severe hypoxic-ischaemic encephalopathy (HIE) based on modified Sarnat or Thompson classification, requiring therapeutic hypothermia • Neonatal sepsis (early or late): early-onset sepsis to be defined as sepsis within the first 72 hours of birth, and late-onset sepsis as sepsis after 72 hours of birth. • Surgery under general anaesthesia for gastrointestinal or other anomalies: Oesophageal atresia, gastroschisis, exomphalos, congenital diaphragmatic hernia, malrotation, congenital duodenal obstruction, small intestinal atresia, colon atresia, Hirschsprung Disease, microcolon, anorectal anomalies. Other surgical conditions such as thoracic and renal will be included if their expected duration of hospital stay is more than two weeks. Infants with cardiac surgical conditions will be excluded since they are a critically high-risk group and will be moving between NICU, Paediatric Intensive Care Unit (PICU) and ward on a routine basis.
Exclusion criteria
Neonates with acquired surgical conditions such as necrotizing enterocolitis (NEC).
Outcome results
None listed