Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.

NCT03431558 | Unknown Phase 3 DMC

• 1 other identifier: SLAB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis; Necrotizing Enterocolitis

Keywords

Bovine Lactoferrin, Neonatal infection, Low Birth Weight

Outcome Measures

Primary Outcomes (2)

• Late onset sepsis (LOS) in Low Birth Weight.

  Reduction in late onset sepsis (LOS) in Low Birth Weight babies.

  1 month

• Optimal dosage of bLF

  Deduce optimal dosage of bLF in LBW babies.

  1 month

Secondary Outcomes (2)

• Necrotizing Enterocolitis in LBW babies

  1 month

• Neonatal Mortality at 1 month of life.

  1 month

Study Arms (3)

Group 1

EXPERIMENTAL

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)

Group 2

EXPERIMENTAL

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)

Group 3

PLACEBO COMPARATOR

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)

Interventions

bLF (Bovine lactoferrin) COMBINATION_PRODUCT

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.

Also known as: bLF

Group 1; Group 2

Glucon-D 99.4% (Placebo) DRUG

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

Also known as: Placebo

Group 3

Eligibility Criteria

• Age: 48 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• University of Sydney: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (10)

• Khan A, Kinney MV, Hazir T, Hafeez A, Wall SN, Ali N, Lawn JE, Badar A, Khan AA, Uzma Q, Bhutta ZA; Pakistan Newborn Change and Future Analysis Group. Newborn survival in Pakistan: a decade of change and future implications. Health Policy Plan. 2012 Jul;27 Suppl 3:iii72-87. doi: 10.1093/heapol/czs047.

  PMID: 22692418 BACKGROUND

• Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.

  PMID: 15752534 BACKGROUND

• 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.

  BACKGROUND

• Farnaud S, Evans RW. Lactoferrin--a multifunctional protein with antimicrobial properties. Mol Immunol. 2003 Nov;40(7):395-405. doi: 10.1016/s0161-5890(03)00152-4.

  PMID: 14568385 BACKGROUND

• Anderson BF, Baker HM, Dodson EJ, Norris GE, Rumball SV, Waters JM, Baker EN. Structure of human lactoferrin at 3.2-A resolution. Proc Natl Acad Sci U S A. 1987 Apr;84(7):1769-73. doi: 10.1073/pnas.84.7.1769.

  PMID: 3470756 BACKGROUND

• The World Bank. Mortality rate, neonatal (per 1,000 live births) [29/02/2016]. Available from: http://data.worldbank.org/indicator/SH.DYN.NMRT.

  BACKGROUND

• Kramer MS. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Health Organ. 1987;65(5):663-737.

  PMID: 3322602 BACKGROUND

• Rahman S, Hameed A, Roghani MT, Ullah Z. Multidrug resistant neonatal sepsis in Peshawar, Pakistan. Arch Dis Child Fetal Neonatal Ed. 2002 Jul;87(1):F52-4. doi: 10.1136/fn.87.1.f52.

  PMID: 12091293 BACKGROUND

• Morrow AL, Rangel JM. Human milk protection against infectious diarrhea: implications for prevention and clinical care. Semin Pediatr Infect Dis. 2004 Oct;15(4):221-8. doi: 10.1053/j.spid.2004.07.002.

  PMID: 15494945 BACKGROUND

• Ariff S, Soofi S, Aamir A, D'Almeida M, Aziz Ali A, Alam A, Dibley M. Bovine Lactoferrin to Prevent Neonatal Infections in Low-Birth-Weight Newborns in Pakistan: Protocol for a Three-Arm Double-Blind Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 11;10(3):e23994. doi: 10.2196/23994.

  PMID: 33704071 DERIVED

Related Links

• The World Bank Mortality rate ,Neonatal (per,1000 live births) 29/02/2016
• United.Nations Sustainable development goals

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Shabina Ariff, MBBS,FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Michael J Dibley, MB BS, MPH

  University of Sydney

  STUDY CHAIR

• Almas Aamir, MSC

  Aga Khan University

  STUDY DIRECTOR

Central Study Contacts

Sajid B Soofi, MBBS,FCPS,

CONTACT

+922134864798; sajid.soofi@aku.edu

Asghar Ali, MRA,MBA

CONTACT

92 213 493 0051; asghar.ali@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)