Dataset Information

Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial.

ABSTRACT:

Introduction

The oral polio vaccine (OPV) has substantial results in eliminating wild poliovirus and the vaccine of choice in polio eradication. However, the mucosal immunity induced by the OPV is still uncertain. Literature has shown that bovine lactoferrin (BLF) is a safe and useful protein found in cow's milk with extraordinary antimicrobial, antiviral, antiinflammatory and immune-modulatory functions that help children's gut to fight against micro-organisms like poliovirus. However, limited data exist regarding the effect of BLF on polio vaccine immune response. The primary objective is to evaluate the effect of BLF in enhancing mucosal and humoral immunity in children following the administration of oral and inactivated polio vaccines.

Methods and analysis

This is a two-arm double-blinded randomised controlled trial comparing 462 neonates (231 in both groups) receiving either BLF or placebo with breast milk. The intervention is administered from day 1 till 6 weeks of age to a full-term healthy singleton newborn born at the Aga Khan University Hospitals, Karachi, Pakistan. The primary outcome is the seroconversion, 1 month after the receipt of two doses of OPV (at 10 weeks). For descriptive statistical analysis, Stata will be used, the frequency with percentages will be reported to describe baseline characteristics of the participants. A χ² test will be used to compare categorical variables and a simple t test to compare continuous variables. The proportion of seroconversion and shedding will be compared using χ² test or Fisher's exact test.

Ethics and dissemination

The Ethics approval has been granted by the Ethics Review Committee (ERC) of Aga Khan University for the proposed trial (ID: 2019-1955-5013). Furthermore, the National Bioethics Committee (NBC) of Pakistan has also approved the study for human subject research (ID: 4-87/NBC-443/19/669). Study findings will be disseminated through presentations at scientific conferences and educational practice workshops and will be published in an international peer-reviewed scientific journal.

Trial registration number

NCT04432935; ClinicalTrials.gov.

SUBMITTER: Habib A

PROVIDER: S-EPMC9125737 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial.

Habib Atif A Nausheen Sidrah S Nooruddin Shanila S Javed Tooba T Samejo Tariq T Hussain Amjad A Namdev Suneeta S Amirali Sehrish S Umer Muhammad M Sheikh Lumaan L Hussain Imtiaz I Ariff Shabina S Soofi Sajid S

BMJ open 20220524 5

<h4>Introduction</h4>The oral polio vaccine (OPV) has substantial results in eliminating wild poliovirus and the vaccine of choice in polio eradication. However, the mucosal immunity induced by the OPV is still uncertain. Literature has shown that bovine lactoferrin (BLF) is a safe and useful protein found in cow's milk with extraordinary antimicrobial, antiviral, antiinflammatory and immune-modulatory functions that help children's gut to fight against micro-organisms like poliovirus. However, ...[more]

PMID: 35613782

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Project description:ObjectivesTo examine the efficacy of intratracheal dexmedetomidine (Dex) injection for the prevention of the laryngeal response on emergence from general anaesthesia following gynaecological laparoscopic surgery.DesignProspective, randomised, double-blinded, controlled trial.SettingA general hospital, Guangdong Province, China.ParticipantsAll patients who underwent elective laparoscopic gynaecological surgery, aged 18-60 years old, 40-80 kg in weight, American Society of Anesthesiologists class I-II were eligible. Patients were excluded if they had respiratory disease, heart disorders which might represent risk factors of potential complications of Dex such as bradycardia, heart block, coronary heart disease, uncontrolled hypertension or the long-term use of sedative drugs.InterventionPatients were randomly allocated to either receive intratracheal Dex (DT), intravenous Dex (DV) or intravenous saline (CON, n=30, respectively). In the DT and DV groups, Dex (0.5 µg/kg) was diluted and mixed in 1 or 20 mL of saline, respectively, and injected via the intratracheal or intravenous route 30 min before the completion of the surgery.Outcome measuresThe primary outcome was the coughing extent among the three groups. Secondary outcomes included awareness time, extubation time, postoperative visual analogue scale and Steward recovery score.ResultsCompared with the CON group, the extent of coughing was significantly reduced in both the DV group and the DT group. Furthermore, the mean time to awareness (13.4 (4.3) vs 8.8 (2.9), p<0.001) and the extubation time (14.3 (4.3) vs 8.4 (3.6), p<0.001) were reduced in the DT group. Patients in the DT group also experienced better early recovery quality and less pain than those in the CON group. Furthermore, intratracheal Dex administration contributed to improved stability in haemodynamics with no significant side effects.ConclusionsIntratracheal Dex administration may avoid untoward laryngeal responses for patients emerging from general anaesthesia after gynaecological laparoscopy.Trial registration numberChiCTR-IOR-15007611.

Dataset Information

Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial.

Similar Datasets

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