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Trial record 4 of 24 for:    "Enterocolitis" | "Anti-Infective Agents"

Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.

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ClinicalTrials.gov Identifier: NCT03431558
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
University of Sydney
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Dr Shabina Ariff, Aga Khan University

Brief Summary:

Pakistan has the third highest number of neonatal deaths worldwide. During the last two decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per year. Severe infection is the second most leading cause of neonatal mortality, account for 28% of all deaths in Pakistan. Majority of neonatal deaths occur in infants who LBW (birth weight <2500g) and LBW comprises of both preterm / small for gestational age newborns. Breastfeeding helps protect infants from infections by serving as a source of nutrition uncontaminated by environmental pathogens. The protection is due to the multiple anti-infective, anti-inflammatory, and immuno regulatory factors transmitted through milk including secretory antibodies, glycan's, Lactoferrin, leukocytes, cytokines & other components produced by the mother's immune system.

Reduction in neonatal infections and deaths is the aim of this study. The study is being conducted at the Aga Khan University in collaboration with University of Sydney.


Condition or disease Intervention/treatment Phase
Neonatal Sepsis Necrotizing Enterocolitis Combination Product: bLF (Bovine lactoferrin) Drug: Glucon-D 99.4% (Placebo) Phase 3

Detailed Description:

Globally, severe infection is the second leading cause of neonatal mortality. It is one of the indirect leading causes of death in a world. According to Annual report, 28% neonatal deaths were due to preterm baby, 26% due to severe infection , 23% due to asphyxia and 7% neonatal tetanus. Every year, three - fourth deaths occurred in first week and four million babies die each year within first four weeks of birth, whereas, 99% of cases were reported by low and middle income countries.Severe infections are the second major cause of death among neonates in Pakistan. Breastfeeding helps to protect infants from infections due to the multiple anti-infective, anti-inflammatory, and immuno regulatory factors such as secretory antibodies, glycan, Lactoferrin etc. Lactoferrin, the second most abundant protein in human milk has multiple putative functions. A trial in Italy found that the incidence of late-onset sepsis and sepsis related deaths were significantly lower in very LBW infants who were given daily (Bovine Lactoferrin) bLF compared to placebo. One small trial from India, found there was a 79% reduction in neonatal infections in LBW infants who received daily bovine Lactoferrin (bLF) from birth until 28 days. Evidence gaps remain about the appropriate daily prophylactic dose, the optimal method to deliver, and the effectiveness of bLF to prevent neonatal sepsis in LBW infants in low & middle-income countries.The overall goal of the project is to improve newborn survival among low birth weight (LBW) Pakistani infants through provision of a daily prophylactic dose of bLF. The project aim is to prevent neonatal infections, as opposed to the current approach which treats neonatal infections when they occur. The current approach depends on early detection of infections in newborns through post-natal care and treatment with antibiotics, with the potential risk of inappropriate use of antibiotics.A two stage study will be conducted including formative research followed by RCT to evaluate the appropriate daily dose of bLF. At the end of the study the investigators will have developed and tested an appropriate method to deliver bLF to newborns at home & identified the most appropriate dose of bLF to prevent neonatal sepsis in LBW newborns.

This study will be conducted at the Aga Khan University and Hospital, Karachi in two phases. A qualitative study will be conducted followed by a RCT. 300 LBW new born babies will be recruited;all standard operating procedures will be followed for administration of bLF to the neonates. Each arm of the study will be allocated 100 newborns.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group 1: bLF (150 mg) will be administered after 48 hours of age with a single daily dose mixed with milk (preferentially breast milk otherwise premature formula milk).

Group 2: bLF will be administered (300mg) after 48 hours of life with a single daily dose mixed with milk (preferentially breast milk otherwise premature formula milk).

Group 3: Placebo will be administered after 48 hours of life (Placebo will be physically identical to the bLF mixed with breast milk or premature formula milk).

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Randomization will be carried out by Data management unit and all investigators /dispensers and participants will be masked to the randomization.

Clinical Trial Unit (CTU) of the Aga khan university will dispense the randomized supplemnt/placebo

Primary Purpose: Prevention
Official Title: Can Bovine Lactoferrin Prevent Neonatal Infections in Low Birth Weight Babies in Karachi, Sindh, Pakistan.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1

bLF (Bovine Lactoferrin plus Glucan D 99.4%) Dose: 150 mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk).

Duration: 1 month

Combination Product: bLF (Bovine lactoferrin)
BLF administration in two different strengths (150 & 300mg) will be given on the third day of life with a single daily dose mixed with milk for 1 month.

Experimental: Group 2

bLF (Bovine Lactoferrin plus Glucan D 99.4%) Dose: 300mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk).

Duration: 1 month

Combination Product: bLF (Bovine lactoferrin)
BLF administration in two different strengths (150 & 300mg) will be given on the third day of life with a single daily dose mixed with milk for 1 month.

Placebo Comparator: Group 3

Placebo: Only Glucan-D (99.4% glucoseDose: 150 mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk).

Duration: 1 month

Drug: Glucon-D 99.4% (Placebo)
This group will be given 100mg Glucon-D (99.4% glucose) placebo which will be similar in shape, color to the bLF.




Primary Outcome Measures :
  1. Late onset sepsis (LOS) in Low Birth Weight. [ Time Frame: 1 month ]
    Reduction in late onset sepsis (LOS) in Low Birth Weight babies.

  2. Optimal dosage of bLF [ Time Frame: 1 month ]
    Deduce optimal dosage of bLF in LBW babies.


Secondary Outcome Measures :
  1. Necrotizing Enterocolitis in LBW babies [ Time Frame: 1 month ]
    Incidence of Necrotizing Enterocolitis in Low Birth Weight babies

  2. Neonatal Mortality at 1 month of life. [ Time Frame: 1 month ]
    Incidence of Neonatal Mortality at 1 month of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Neonates with:

birth weight ≤ 2500 g and ≥ 1000 grams. gestational age ≥ to 28 +0 weeks to 36+6. family planned on staying in the study area for at least 1 month • parents/ caretaker willing to provide consent. newborn initiated enteral feeding via (gavage feeding with expressed breast milk or formula, direct breast feeding or cup and spoon feeding at or within 48 hours of birth.)

Exclusion Criteria:

Neonate with congenital anomalies. early-onset sepsis. birth weight less than 1000 g. gestational age less than or equal to 27weeks+6 days. history of Chorioamnionitis or maternal group B streptococcus colonization. Reversed or absent end-diastolic flow on maternal umbilical artery Doppler where available.


Information from the National Library of Medicine

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): NCT03431558


Contacts
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Contact: Sajid B Soofi, MBBS,FCPS , +922134864798 ext 4798 sajid.soofi@aku.edu
Contact: Asghar Ali, MRA ,MBA 92 213 493 0051 ext 2279 asghar.ali@aku.edu

Locations
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Pakistan
Aga Khan University Hospital Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Shabina Associate Professor    +92 21 34864357 ext 4357    Shabina.ariff@aku.edu   
Contact: Dr. Saajid B Soofi Soofi, FCPS MBBS    +92 21 99244230 ext 8186    Sajid.soofi@aku.edu   
Sub-Investigator: Neeloy A Alam         
Sub-Investigator: William T Mordi         
Sponsors and Collaborators
Aga Khan University
University of Sydney
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Shabina Ariff, MBBS,FCPS Aga Khan University
Study Chair: Michael J Dibley, MB BS, MPH University of Sydney
Study Director: Almas Aamir, MSC Aga Khan University

Additional Information:
Publications:
Hug L, Sharrow D, You D. Levels & trends in child mortality: report 2017. Estimates developed by the UN Inter-agency Group for Child Mortality Estimation. 2017.
The World Bank. Mortality rate, neonatal (per 1,000 live births) [29/02/2016]. Available from: http://data.worldbank.org/indicator/SH.DYN.NMRT.

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Responsible Party: Dr Shabina Ariff, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03431558     History of Changes
Other Study ID Numbers: SLAB
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Shabina Ariff, Aga Khan University:
Bovine Lactoferrin, Neonatal infection, Low Birth Weight
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Anti-Infective Agents
Neonatal Sepsis
Birth Weight
Body Weight
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lactoferrin