Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06002295 |
| Other study ID # |
SZMC/IRB/Internal/MD/130/19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2020 |
| Est. completion date |
November 19, 2021 |
Study information
| Verified date |
August 2023 |
| Source |
Sheikh Zayed Federal Postgraduate Medical Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Neonatal sepsis in one of the leading cause of death in developing countries.
Umbilical cord care is important as it may lead to infection. Topical treatment can help to
reduce the chances of infection as well as increase the chances of early removal. In this
regard methylated spirit and chlorhexidine are found to be effective.
Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit
in newborns for prevention of omphalitis and neonatal sepsis.
Materials and Methods: This randomized control trial was carried out in neonatal unit of
Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were
enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated
spirit was used. Neonates were followed till 10th day of life. Careful examination was done
for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs
and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.
Description:
Introduction:
Neonatal sepsis in one of the leading causes of death in neonates in developing countries.
Infection of the umbilical cord often leads to infection in the blood. World Health
Organization (WHO) recommends 4% chlorhexidine to prevent omphalitis and neonatal sepsis. In
Pakistan the investigators use methylated spirit for prophylaxis of omphalitis as 4%
chlorhexidine is not available and expensive to use. Some commercial gels containing 2%
chlorhexidine is available, but these are not as effective as methylated spirit.
Chlorhexidine gel is an antiseptic agent with broad-spectrum bactericidal and bacteriostatic
properties effective against gram-negative bacteria and fungi with rapid pathogen killing
rates. Methylated spirit on the other hand is both bactericidal, mycobactericidal,
fungicidal, and viricidal agent.
In Pakistan Staphylococcal aureus is common pathogen in umbilical discharge. Some low cost
prevention therapy should be used. Methylated spirit is commonly used for cord care. A study
was conducted to explore about cord care practices in African setting which showed that 73.2%
respondents consider methylated spirit as most important agent for cord care.
Chlorhexidine is available in different concentrations for antiseptic purpose. Efficacy of
all concentrations is comparable but 4% chlorhexidine concentration is more effective in
inhibiting organism's flora as compared to 2% chlorhexidine. Since then, multiple studies
were done to compare between methylated spirit and 4% chlorhexidine. Methylated spirit is
equally safe where 4% chlorhexidine is unavailable.
In Pakistan 57% deaths occur in neonatal period. Pakistan has highest neonatal mortality rate
of 42 per 1000 live births. In developing countries neonatal sepsis is aggravated by home
deliveries, antibiotic resistance and less medical staff. The most important way to decrease
mortality and morbidity due to infections is prevention at an early stage. According to a
study conducted in Karachi, omphalitis is 217.4/1000 live births from which moderate-severe
omphalitis is 170/1000 live births and associated with sepsis is 20.4/1000 live births.
Various antiseptics used in neonatal intensive care units include chlorhexidine, alcohol,
iodine, hexachlorophene & octenidine. Each agent having its own advantages and adverse
effects. However best antiseptic is yet to be determined.
World Health Organization (WHO) recommends application for 4 percent chlorhexidine in high
neonatal mortality area and methylated spirit for cord care while methylated spirit is
commonly used agent for cord care. One study conducted shows that applying chlorhexidine on
cord in neonatal intensive care unit decreases mortality rate and decreases time of
separation of cord.
Methylated spirit and chlorhexidine both have comparable efficacy and can be used in areas of
non-availability of chlorhexidine and whenever chlorhexidine is not safe to use as in very
preterm neonates. In Pakistan there is no population based study published on this issue this
study aimed to compare the effectiveness of methylated spirit and 4% chlorohexidine from
prevention of omphalitis and neonatal sepsis. This study will help to establish the use of
methylated spirit in prevention of omphalitis and neonatal sepsis at low price and easy
availability.
Methodology:
It was a randomized controlled trial done at the Neonatology unit, Department of Pediatrics,
Shaikh Zayed Hospital, Lahore. For a period of 12 months from September 2020 to September
2021 with the hypothesis that methylated spirit is equally effective as 4% chlorhexidine in
preventing omphalitis and sepsis in neonate. 300 newborns were included by probability
consecutive sampling in study with 150 newborns in each group with confidence interval of 95%
and margin of error 5%. Sample size was calculated using Raosoft sample size calculator.
After approval from the hospital ethical committee, neonates fulfilling inclusion and
exclusion criteria were selected. Written informed consent was obtained from the parents.
Full instructions to avoid confounding variables like maintaining temperature and hygiene of
newborn, frequent diaper change, avoidance of herbal tonics and cow milk were given to
mothers.
In group "A" mothers were advised the topical application of 4% chlorhexidine generously over
cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean
cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and
base thrice a day.
Neonates were followed till 10th day of life and careful examination was done for cord
separation and any signs of omphalitis or sepsis. Primary outcome measure was omphalitis
which was characterized by local inflamed cord. Secondary outcome measure was sepsis which
was characterized by signs and symptoms such as fever, reluctance to feed, respiratory
difficulty, irritability. Treatment success was labelled if there was no evidence of
omphalitis or sepsis. If omphalitis or evidence of sepsis was present, the patient was
treated as per hospital protocol. Data was collected according to proforma.
Statistical Analysis:
Data was entered in SPSS v.23.0 and was analyzed through it. The numeric variables like
gestational age at birth and birth weight were presented as mean ± standard deviation, while
the categorical variables like gender of the neonate, omphalitis and sepsis were presented as
frequency (%). Both groups were compared for omphalitis and sepsis by using the chi-square
(ﬡ²) test. P-value ≤ 0.05 was kept as significant. Data was stratified for gender of the
neonate, gestational age at birth and birth weight to deal with the effect modifiers.
Post-stratification, Chi-Square test was applied to compare both groups for omphalitis and
sepsis in each strata. P-value ≤ 0.05 was kept as significant.
