Necrotizing Enterocolitis Clinical Trial
— FortiColos-?Official title:
Bovine Colostrum to Fortify Human Milk for Preterm Infants: A Randomized, Controlled Trial
NCT number | NCT03822104 |
Other study ID # | FortiColos-CN |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | July 8, 2021 |
Verified date | January 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not sufficient to support nutrient requirements for growth of very preterm infants. Thus, it remains a difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and minimize NEC and LOS in the postnatal period of very preterm infants. Mother´s own milk (MM) is considered the best source of EN for very preterm infants and pasteurized human donor milk (DM) is the second choice if MM is absent or not sufficient. The recommended protein intake is 4-4.5 g/kg/d for very low birth infants when the target is a postnatal growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per day. Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC protection, and nutrient assimilation, even across species. Studies in preterm pigs show that feeding BC alone, or DM fortified with BC, improves growth, gut maturation, and NEC resistance during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs. On this background, the investigators hypothesize that BC, used as a fortifier for MM or DM, can reduce feeding intolerance than conventional fortifiers.
Status | Completed |
Enrollment | 139 |
Est. completion date | July 8, 2021 |
Est. primary completion date | June 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Weeks |
Eligibility | Inclusion Criteria: 1. Very preterm infants born between gestational age 26 + 0 and 30 + 6 weeks (from the first day of the mother's last menstrual period and/or based on fetal ultrasound) 2. DM is given at the unit when MM is absent (or insufficient in amount) 3. Infants judged by the attending physician to be in need of nutrient fortification, as added in the form of HMF to MM and/or DM 4. Signed parental consent Exclusion Criteria: 1. Major congenital anomalies and birth defects 2. Infants who have had gastrointestinal surgery prior to randomization 3. Infants who have received IF prior to randomization |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Nanshan People's Hospital | Shenzhen | |
China | Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH) | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Per Torp Sangild |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Volume of gastric residual | Volume of aspirated gastric residuals in ml | From birth to hospital discharge, or up to 14 weeks | |
Other | Color of gastric residual | The color of aspirated gastric residuals categorized into 7 colours | From birth to hospital discharge, or up to 14 weeks | |
Other | Incidence of bloody gastric residual | Number of infants in each group have had blood in the gastric residual | From birth to hospital discharge, or up to 14 weeks | |
Other | Frequency of stool per day | Frequency of stool passed each day | From birth to hospital discharge, or up to 14 weeks | |
Other | Amount of the stool | Using a 4-level pre-defined scale Amount of stool on the diaper: the percentage of area covered by stool on the diaper.
1 smear; 2 up to 25%; 3 25-50%; 4 >50% |
From birth to hospital discharge, or up to 14 weeks | |
Other | Color of the stool | The color of stools categorized into 6 colors | From birth to hospital discharge, or up to 14 weeks | |
Other | Consistency of the stool | Using a 4-level pre-defined scale | From birth to hospital discharge, or up to 14 weeks | |
Other | Total daily volume of enteral nutrition (EN) and parenteral nutrition (PN) | Volume of EN (including MM, DM, infant formula, and fortification) and PN in take | From birth to hospital discharge, or up to 14 weeks | |
Other | Levels of macronutrients intake from EN and PN | Calculated based on the volume and composition of EN and PN | From birth to hospital discharge, or up to 14 weeks | |
Primary | Incidence of feeding intolerance | Number of infants in each group diagnosed with feeding intolerance for at least once. Feeding intolerance is defined as any pause of fortification or withhold of enteral feeding. | From start of intervention until the infants reach PMA 35+6 weeks or are not in need of fortification due to sufficient growth, whichever comes first | |
Secondary | Body weight | Weight gain in grams per kg body weight from birth to discharge. Weight at different time points will be calculated into z-scores according to a reference. Delta z-scores will be used to evaluate growth and for comparison between groups. | Measured weekly from the start of intervention until hospital discharge, or up to 14 weeks | |
Secondary | Body length | Recorded as a measure of growth in cm by standardized measuring procedures | Measured weekly from the start of intervention until hospital discharge, or up to 14 weeks | |
Secondary | Head circumference | Recorded as a measure of head growth in cm by standardized measuring procedures | Measured weekly from the start of intervention until hospital discharge, or up to 14 weeks | |
Secondary | Incidence of necrotizing entercolitis (NEC) | Number of infants in each group diagnosed with necrotizing enterocolitis (NEC) defined as Bell's stage II or above (Kliegman & Walsh 1987) | From the start of intervention to hospital discharge, or up to 14 weeks | |
Secondary | Incidence of late-onset sepsis (LOS) | Number of infants in each group diagnosed with late-onset sepsis defined as clinical signs of infection >2 days after birth with antibiotic treatment for =5 days (or shorter than 5 days if the participant died) with or without one positive bacterial culture in blood or cerebral spinal fluid (CSF) | From the start of intervention to hospital discharge, or up to 14 weeks | |
Secondary | Time to reach full enteral feeding | Number of days to full enteral feeding is reached - defined as the time when >150 ml/kg/d is reached and parenteral nutrition has been discontinued | From birth to hospital discharge, or up to 14 weeks | |
Secondary | Days on parenteral nutrition | Number of days that the infant receives intravenous intakes of protein and/or lipid and/or glucose | From birth to hospital discharge, or up to 14 weeks | |
Secondary | Length of hospital stay | Number of days in hospital, defined as days from birth until final discharge | From birth to hospital discharge, or up to 14 weeks |
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