Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03085277
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2017-03-14
Brief Title:
Bovine Colostrum for Preterm Newborns
Sponsor:
Per Torp Sangild
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Bovine Colostrum Versus Preterm Formula as the First Supplemental Nutrition for Very Preterm Infants a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreColos-RCT
Brief Summary:
Feeding intolerance is a common problem in very preterm infants due to their immature digestive system This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition PN Prolonged time to full enteral feeding may predispose these infants to a higher risk of growth retardation infections and organ dysfunctions eg liver brain Mothers own milk MM is considered the optimal nutrition for preterm infants and is superior to infant formula including preterm formula PF in stimulating gut maturation feeding tolerance resistance against necrotizing enterocolitis NEC and late-onset sepsis LOS and long-term neurodevelopmental outcomes However MM is often absent or not available in sufficient amounts during the first days or weeks after preterm delivery Human donor milk DM is probably a better supplement to MM than PF but DM is not available for all hospitals To supplement insufficient MM during the early neonatal period in hospital settings with no access to donor milk we suggest that bovine colostrum BC may be used instead of PF for very preterm infants during early life BC the first milk from cows after birth is a rich source of protein and bioactive components including lactoferrin lysozyme lactoperoxidase immunoglobulins and various growth factors such as IGF-I and -II EGFs and TGF-β BC has repeatedly been shown to improve gut maturation and NECLOS resistance in a well-established piglet model of preterm infants We suggest a randomized controlled trial to investigate the effects of BC vs PF supplemented to MM during the first 2 weeks on the time to full enteral feeding in very preterm infants
Detailed Description:
The Precolos-RCT is a multicenter two-arm unblinded randomized controlled trial Infants are randomized to an intervention group which receives BC and a control group which receives PF In detail MM is always the first priority when available When MM is not available or the available amounts do not fulfill the needs infants in BC group will receive BC and control infants will receive PF as the supplementary diets Feeding should be initiated within 24-48 h after birth following a pre-defined nutritional guideline BC intervention should not exceed postnatal day 14 After the intervention period the participants in both groups will receive standard feeding which is the available MM with or without supplemental preterm infant formula Infants will be followed until discharge home or reach a postconceptional age of 37 weeks whichever comes first discharge home37 wks
In general parenteral and enteral nutrition should be given according to the following description
Parenteral and enteral nutrition will be given according to the targeted daily fluid energy and protein levels suggested by ESPGHAN and CSPEN Enteral nutrition should be given according to the feeding guideline and PN is used to ensure the targeted protein energy and lipid intake when enteral feeding is insufficient to provide fluid and nutrition Participating hospitals should try their best to assist mothers in expressing their colostrum and milk and giving mothers colostrum as the first feeds Enteral feeding should be given as soon as possible within 24h of life after randomization for infants with BW 750g For infants with BW 750 g first feeding should be given within 24 h if mothers colostrum is available Otherwise first feeding should wait until day 2 for mothers to express their own colostrum Mothers colostrum and MM is given as much as available and when it is not available or in an insufficient amount BC or PF is used during the intervention period to supplement the lacking volume Infants should receive an initial feeding volume of 5-10 mlkgd and the volume should increase by 5-20 mlkgd until 150-160 mlkgd depending on their BW The advancing rate of feeding should follow the suggested pace but also be adjusted according to the tolerability of the infants If feeding intolerance occurs feeding should be at a flat rate or be withheld according to predefined criteria in parenteral and enteral nutrition SOP If infants can tolerate more feeding can be increased faster Since total protein intake should be within 4-45 gkgd according to the ESPGHAN guideline25 the maximal daily volume of BC should be calculated based on the available volume of MM and protein levels in MM and BC The protein supply from MM is calculated assuming a protein content of 15 g100 mL27 during the first 14 days and the protein supply from colostrum is 8 g100 mL may adjust to changes according to the product specification of the batch in use when the difference is bigger than 5 At the end of the intervention period the enteral feeding in the intervention group will be gradually transferred to standard feeding MM with supplemental PF when needed Participants in the control group will keep receiving standard feeding after the intervention period However if a participant reaches term during their hospital stay PF may be changed to term formulas according to local guidelines The participating hospitals use four types of PF with similar nutrients composition and will remain the same throughout the study
Although in the intervention group infants should receive supplemental BC instead of PF during the intervention period there is a possibility that PF and BC are simultaneously used as the supplemental diets For example when a participant in the intervention group can tolerate a higher EN volume than the available volume of MM plus the maximum daily volume of BC due to max protein limitation PF needs to be given to fulfill the total EN volume Importantly the volume of each milk diet will need to be adjusted according to the maximal protein intake of 4-45 gkgd When BC intake has reached the maximal volume due to protein limitation but fluid requirement still needs to be fulfilled by PN the PN should be given with an amino acid level of 05 gkgd other nutrients are provided accordinglyand BC volume should be reduced by 625 mlkgd A detailed guideline for parenteral and enteral nutrition is described in an SOP Parenteral and enteral nutrition SOP
In general parenteral and enteral nutrition should be given according to the following description
Parenteral and enteral nutrition will be given according to the targeted daily fluid energy and protein levels suggested by ESPGHAN and CSPEN Enteral nutrition should be given according to the feeding guideline and PN is used to ensure the targeted protein energy and lipid intake when enteral feeding is insufficient to provide fluid and nutrition Participating hospitals should try their best to assist mothers in expressing their colostrum and milk and giving mothers colostrum as the first feeds Enteral feeding should be given as soon as possible within 24h of life after randomization for infants with BW 750g For infants with BW 750 g first feeding should be given within 24 h if mothers colostrum is available Otherwise first feeding should wait until day 2 for mothers to express their own colostrum Mothers colostrum and MM is given as much as available and when it is not available or in an insufficient amount BC or PF is used during the intervention period to supplement the lacking volume Infants should receive an initial feeding volume of 5-10 mlkgd and the volume should increase by 5-20 mlkgd until 150-160 mlkgd depending on their BW The advancing rate of feeding should follow the suggested pace but also be adjusted according to the tolerability of the infants If feeding intolerance occurs feeding should be at a flat rate or be withheld according to predefined criteria in parenteral and enteral nutrition SOP If infants can tolerate more feeding can be increased faster Since total protein intake should be within 4-45 gkgd according to the ESPGHAN guideline25 the maximal daily volume of BC should be calculated based on the available volume of MM and protein levels in MM and BC The protein supply from MM is calculated assuming a protein content of 15 g100 mL27 during the first 14 days and the protein supply from colostrum is 8 g100 mL may adjust to changes according to the product specification of the batch in use when the difference is bigger than 5 At the end of the intervention period the enteral feeding in the intervention group will be gradually transferred to standard feeding MM with supplemental PF when needed Participants in the control group will keep receiving standard feeding after the intervention period However if a participant reaches term during their hospital stay PF may be changed to term formulas according to local guidelines The participating hospitals use four types of PF with similar nutrients composition and will remain the same throughout the study
Although in the intervention group infants should receive supplemental BC instead of PF during the intervention period there is a possibility that PF and BC are simultaneously used as the supplemental diets For example when a participant in the intervention group can tolerate a higher EN volume than the available volume of MM plus the maximum daily volume of BC due to max protein limitation PF needs to be given to fulfill the total EN volume Importantly the volume of each milk diet will need to be adjusted according to the maximal protein intake of 4-45 gkgd When BC intake has reached the maximal volume due to protein limitation but fluid requirement still needs to be fulfilled by PN the PN should be given with an amino acid level of 05 gkgd other nutrients are provided accordinglyand BC volume should be reduced by 625 mlkgd A detailed guideline for parenteral and enteral nutrition is described in an SOP Parenteral and enteral nutrition SOP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None