Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926390
Other study ID # FMASU 50 / 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date September 15, 2019

Study information

Verified date June 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.


Description:

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

1. Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.

2. Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.

3. Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.

II. Thorough clinical assessment:

1. Weight and Occiptofrontal circumference (twice weekly).

2. Complete examination including cardiovascular, respiratory, abdominal and neurological examination.

III. Laboratory investigations:

1. Complete blood picture, C-reactive protein on admission and repeated twice weekly

2. Blood culture before starting treatment and with any suspected sepsis.

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 15, 2019
Est. primary completion date June 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- • Preterm Neonate having a gestational age equal or less than 34 weeks at birth, admitted in Ain-Shams University NICUs

Exclusion Criteria:

- • Maternal risk factor of early onset sepsis, chorioamnionitis.

- Proved early onset sepsis.

- Life-threatening congenital abnormalities.

- Inborn error of metabolism.

- Chromosomal aberrations.

- Neonates with underlying gastrointestinal problems (such as GIT anomalies) that prevent enteral feeding.

- Perinatal asphyxia.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bovine colostrum
bovine colostrum for first 2 weeks

Locations

Country Name City State
Egypt Medicin Giza Abasseya

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Late Onset Sepsis in the three groups Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system From time of randomization to discharge from nicu or death whichever comes first
Primary The incidence of Necrotizing Enterocolitis in the three groups Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging From time of randomization to discharge from nicu or death whichever comes first
Primary The change of Active T regulatory cells In the three groups Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3 Change from base line at randomization and after intervention by 1 week
Secondary 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 Feeding intolerance From time of randomization to discharge from nicu or death whichever comes first
Secondary Neonatal mortality Number of deaths in the study group From time of randomization to discharge from nicu or death whichever comes first
Secondary Duration of hospital stay Duration of hospital stay From time of randomization to discharge from nicu or death whichever comes first
See also
  Status Clinical Trial Phase
Completed NCT03380013 - OMT to Improve Feeding After Hypothermia N/A
Completed NCT05687708 - Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia N/A
Completed NCT05729828 - Psychometric Properties of the SMART Feeding Tool
Not yet recruiting NCT04812249 - Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants
Completed NCT01603368 - Prophylactic Probiotics to Extremely Low Birth Weight Prematures Phase 2
Withdrawn NCT01337921 - A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants N/A
Not yet recruiting NCT06336668 - Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation N/A
Not yet recruiting NCT05861531 - Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes N/A
Not yet recruiting NCT04599010 - Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty N/A
Recruiting NCT05525091 - Neoneur Feeding System Functionality in the Clinic N/A
Completed NCT05310851 - The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm N/A
Completed NCT03369093 - RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia N/A
Completed NCT05307497 - An Exploration of Antenatal Hand Expression.
Completed NCT03371927 - Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization N/A
Recruiting NCT06417385 - taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge N/A
Completed NCT04400175 - Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial N/A
Recruiting NCT04246333 - Duodenal Feeds in Very Low Birth Weight Infants N/A
Completed NCT03280381 - Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding N/A
Completed NCT04945967 - A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial N/A
Completed NCT04025827 - Weight Patterns in the Month After Birth