Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926390|
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Late Onset Neonatal Sepsis Necrotizing Enterocolitis of Newborn Feeding; Difficult, Newborn||Dietary Supplement: Bovine colostrum||Not Applicable|
The study was interventional, double blinded and randomized trial ، performed on preterm neonates( <34 week) admitted on Ain ShamsUniversity (ASU) neonatal intensive care units (NICU) after considering exclusion criteria.
The enrolled patients was subdivided into two groups; group A are infants with non bovine colstrum and group B with bovine colostrum All infants received the standard neonatal care and underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.
I. Data Collection: Careful history taking
- Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.
- Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.
- Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.
II. Thorough clinical assessment:
- Weight and Occiptofrontal circumference (twice weekly).
- Complete examination including cardiovascular, respiratory, abdominal and neurological examination.
III. Laboratory investigations:
- Complete blood picture, C-reactive protein on admission and repeated twice weekly
- Blood culture before starting treatment and with any suspected sepsis.
- In first 24 hours and the end of second week : Collecting peripheral blood mononuclear cells to be analyzed for cellular parameters by flow cytometry (CD4 T cells, CD25 L, FOXP3). Three subsets of CD4+ T cells will be defined according to CD25 staining: CD25- , CD25 low, and CD25 high. Cells expressing CD25 high will be chosen and gated for the detection of FOXP3+ T cells.
IV. Radiological investigations:
Chest X-ray (It was done on admission and repeated when needed). Abdominal X-ray (when necrotizing enterocolitis is suspected). Abdominal ultrasound (when necrotizing enterocolitis is suspected).
V. Follow-up and end-point of the study:
All infant underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.NPO for more than 24 hours
The following primary outcome data was recorded:
- Clinical examination and laboratory investigations when clinically indicated for evidence of sepsis.
- Clinical examination and radiological investigations when clinically indicated for evidence of NEC.
A secondary outcome measure includes weight increment per kg per week, duration of hospitalization, mortality if any, monitoring adverse effects of treatment (if any); such as emesis, increased gastric residuals, increased abdominal girth, diarrhea, skin rash. Long term outcome includes necrotizing enterocolitis, and intracranial hemorrhage.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates|
|Actual Study Start Date :||September 15, 2018|
|Actual Primary Completion Date :||June 15, 2019|
|Actual Study Completion Date :||September 15, 2019|
No Intervention: Non bovine colostrun
Preterm received preterm formula
Active Comparator: Bovine colostrum group
Preterm received bovine colostrum as trophic feeding
Dietary Supplement: Bovine colostrum
bovine colostrum for first 2 weeks
- Incidence of Late Onset Sepsis in the three groups [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system
- The incidence of Necrotizing Enterocolitis in the three groups [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging
- The change of Active T regulatory cells In the three groups [ Time Frame: Change from base line at randomization and after intervention by 1 week ]Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3
- Feeding intolerance is defined as presence of at least 3 consecutive days of any of the following:emesis, gastric residuals, diarrhea, blood in stools or abnormally enlarged bowel loops [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]Feeding intolerance
- Neonatal mortality [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]Number of deaths in the study group
- Duration of hospital stay [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]Duration of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926390
|Giza, Abasseya, Egypt, 05000|
|Principal Investigator:||Hisham Awad||professor of pediatrics Ain Shams university|