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groups
VAS at birth OPV at birth
(N = 116) (N = 116)
Table 1 Baseline characteristics of the two randomisation
Enrolledgroups
in rainy season, n (%)
Enrolled at NH, n (%)
70 (60)
VAS 102 at (88) birth
71 (61)
OPV99 at(85)
birth
(N = 116) (N = 116)
Living inside study area, n (%) 34 (29) 36 (31)
Enrolled in rainy season, n (%) 70 (60) 71 (61)
Twin, n Enrolled (%) at NH, n (%) 26102 (22) (88) 99 24 (85) (21)
Admission Living to inside neonatal studynursery, area, n (%) n (%) 2934 (25) (29) 36 30 (31) (26)
Age at inclusion, Twin, n (%) days (10–90 centiles) 2.5 26 (1–10) (22) 24 (1–10) (21)
Birth weight,
Admission
kg (10–90
to neonatal
centiles)
nursery, n (%)
2.21 (1.66-2.45)
29 (25)
2.22
30
(1.66-2.46)
(26)
Age at inclusion, days (10–90 centiles)
Ballard score* (10–90 centiles)
2.5 (1–10)
36 (27–43)
2 (1–10)
36 (27–43)
Birth weight, kg (10–90 centiles) 2.21 (1.66-2.45) 2.22 (1.66-2.46)
Median maternal age, years
23 (16–29) 22 (17–32)
Ballard score* (10–90 centiles) 36 (27–43) 36 (27–43)
(10–90 centiles)
Median maternal age, years
23 (16–29) 22 (17–32)
Maternal (10–90 schooling, centiles) n (%)
NoneMaternal schooling, n (%)
3 23 (20) 24 (21)
23 (20) 24 (21)
Unknown 1 (1) 1 (1)
Unknown
Maternal MUAC, mm (10–90 centiles)
1 (1)
232 (208–276)
1 (1)
238 (208–284)
Maternal Abbreviations: MUAC, mm NH(10–90 National centiles) hospital; MUAC232 Mid (208–276) upper arm circumference. 238 (208–284)
*Only available for children enrolled at the national hospital.
Abbreviations: NH National hospital; MUAC Mid upper arm circumference.
*Only available for children enrolled at the national hospital.
Methods and supplemented. All mothers were encouraged to take
setting
their child to a health centre at 6 weeks of age to get
and supplemented. The BHP runs a Health and Demographic Surveillance System
BCG, OPV, andAll DTP. mothers At everywere home encouraged visit the assistants to take
(HDSS) in six districts of Bissau, the capital of Guinea-Bissau.
their child checked to the a health children’s centre vaccination at 6 weeks cardsof andage pointed to get
Since 2002 the BHP has followed a cohort of LBW children from
BCG, the out OPV, whole missing and capital. DTP. vaccines All At newborn for every thechildren mothers home weighing visit to ensure theless assistants that than all 2.5
checked kg children at the discharge children’s got OPV. from the Enrolment vaccination maternity staff ward cards did of the notand national take pointed part hospital
out missing (NH) the follow-up are vaccines invited of to the participate. for children. the mothers At time toof ensure the trial, that 13% of all
the children born at the NH were LBW. The children and their
children got OPV. Enrolment staff did not take part in
mothers Interventions are driven home from the hospital. A map is drawn
the follow-up describing Vitamin Aof the was the localisation given children. as aof 0.5 their ml houses, oral supplement GPS coordinates which
are was recorded, slowly released and a photo intoof the mouth house and of the mother child with is taken a
Interventions to sterile ensure syringe that the by team a will nurse. be able Theto supplement localise the child came at in
subsequent visits. When a child moves, a relative a neighbour
Vitamin dark A glass was given bottlesas thata 0.5 were mlprepared oral supplement at Skanderborg which
takes the team to the new address. In this way very few children
was slowly Pharmacy,
are lost released Denmark,
to follow up. intoand LBW thecontained children mouth 20
living ofdoses inside the child of 25000
the BHP with IU
study a
vitamin A as retinyl palmitate and 10 IU vitamin E per
sterilearea syringe who are by born aat nurse. home are The recruited supplement when they come camefor
in
their 0.5 ml first oil. vaccinations The bottles at one were of the kept three at health 2-8°C. centres Trivalent
dark glass in
the OPV study was
bottles
area. supplied
that
In Guinea-Bissau through
were prepared
the LBW national
at
children immunisation
Skanderborg
do not receive
Pharmacy,
BCG programme Denmark,
at birth, but and and
are administered contained
told to come back orally. 20 doses
when There of 25000
they have wasgained
noIU
Figure 1 Trial profile.
vitamin weight, blinding. A as and retinyl they typically palmitate get BCG and together 10 IUwith vitamin the DTP E and per
0.5 ml OPV oil. scheduled The bottles at 6 weeks were of age. kept at 2-8°C. Trivalent
OPV was supplied through the national immunisation
The neonatal nursery offers a very basic care level with
programme
possibility
and
of phototherapy
administered
and intravenous
orally. There
infusion.
was
Intubation
no
Figure 1 Trial profile.
blinding. and oxygen therapy was not possible at the time the trial was Figure 1 Trial profile.
Primary outcome: infant mortality
The LBW children were visited within the first 3 days
after enrolment, and children living inside the study area
Outcomes conducted. Admitted children did often share the available
Primary incubators. outcome: The infant service mortality of the neonatal nursery is free, and
Thechildren LBW children of all gestational were visited ages are within admitted. the first There 3 days is no
after
possibility
enrolment,
of
and
transmission
children
to
living
a higher
inside
specialised
the study
unit.
area
were visited on day 1–3 after enrolment to check for adverse
events. All children who had not died, moved or
enrolment
The study was initiated 20 February 2008. LBW children
wereidentified travelling at were the hospital visitedwere at 2, examined 6, and 12 by a months doctor or ofa
age trained (Figure nurse 1). The who children also assessed living maturity inside the using BHPBallard study score
area[16]. were Anthropometric furthermore measurements followed by the were HDSS. obtained If and the the
child child moved was examined. outside Bissau Eligible or were was boys absent with ata the weight visit, below
relatives 2.5 kg. orExclusion neighbours criteria were were asked major if the malformations, child was still female
alivesex, and and howeight soonat they enrolment would of be≥ told 2500 ifg. the Children child died. who had
Children already travelling received at BCG 12and months children were with visited clinical again signs at of vitamin
15–18 A deficiency months of were age. also When excluded, a deathas was were registered, children that thewere
assistant
too sick
asked
to be
for
discharged
the child’s
by
health
local standards.
card. A verbal
These
autopsy
was conducted around three months after the
children
were referred for treatment. There was no age criterion, as all
children weighing less than 2500 g and coming for their first
death by a trained assistant. A local doctor read the autopsyold,
and and proposed the age distribution a diagnosis. is described The causein of Table death 1. The in mothers
vaccines were eligible. The oldest child enrolled was 64 days
broad were categories informed was of the determined study the later local after language, reading Creole, the and
verbal got autopsy a written and explanation taking into of the account study the in the local official doctor’s
diagnosis and possible hospital records. language,
diagnosis Portuguese. and possible Oral and hospital written records. consent was obtained. The mother
We signed collected the enrolment information on if she temperature, could write, respiratory if not she put
frequency, a fingerprint, weight and gain an and independent a few other observer variables signed inthe the form.
firstProvided three days consent, after enrolment the mother todrew be able a lot to from detect a bag. possibledecided
adversewhich effects treatment, of the intervention VAS or OPV, her (which son would we did receive at
The lot
not
enrolment.
find); however,
Randomisation
we did not
was
collect
done in
information
blocks of 24.
on
The bags
were prepared by the study supervisor; each bag contained 24
stapled lots in separate opaque envelopes. Twins were allocated
the same treatment to prevent potential confusion regarding
were visited on day 1–3 after enrolment to check for adverse
events. All children who had not died, moved or
were travelling were visited at 2, 6, and 12 months of
age (Figure 1). The children living inside the BHP study
area were furthermore followed by the HDSS. If the
child moved outside Bissau or was absent at the visit,
relatives or neighbours were asked if the child was still
alive and how soon they would be told if the child died.
Children travelling at 12 months were visited again at
15–18 months of age. When a death was registered, the
assistant asked for the child’s health card. A verbal autopsy
was conducted around three months after the
death by a trained assistant. A local doctor read the autopsy
and proposed a diagnosis. The cause of death in
broad categories was determined later after reading the
verbal autopsy and taking into account the local doctor’s
We collected information on temperature, respiratory
frequency, weight gain and a few other variables in the
first three days after enrolment to be able to detect possible
adverse effects of the intervention (which we did
not find); however, we did not collect information on
neonatal 2 INTENSIVE CARE Vol. 29 No. 4 Fall 2016 neonatal INTENSIVE CARE Vol. XX No. X Xxxx XXXX 45
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