Many middle-income countries are facing an epidemic of
blindness due to retinopathy of prematurity (ROP) as a
result of a combination of uncontrolled oxygen delivery and
greater survival of preterm babies [1]. In India, even
though neonatal mortality rates have declined [2], awareness
and interventions for preventing vision impairment from ROP
have not increased proportionately [3]. Poorly regulated
supplemental oxygen is an important risk factor for ROP [4].
Estimates suggest that 32,300 infants, approximately 10% of
whom are in India, become blind or visually impaired from
ROP every year [5]. A program to reduce blindness from ROP
was launched by the Ministry of Health in 2013, supported by
the Queen Elizabeth Diamond Jubilee Trust, and managed by
the Indian Institute of Public Health (IIPH), Hyderabad [6].
Conducted in one of the four states delivering the program,
which includes nurse training, this study investigated
whether oxygen was being monitored satisfactorily in four
district level Special Newborn Care Units (SNCU).
MethodsA state reflecting the
demographic profile of India, with an infant mortality rate
within the range likely to make the state at risk of ROP
blindness [7] was selected. In this state, the program was
implemented in four SNCUs – one in a medical college and
three in district-level hospitals. During eight weeks in
mid-2017, each SNCU was visited once for three days. Each
SNCU was allocated a code (A-D) to maintain anonymity. In
units A and B, only the nurses in-charge and ROP nurses (not
directly involved in patient care) had been included in the
training; whereas in units C and D, all nurses were
included.
To assess nurses’ understanding of
ROP, multiple-choice questions (MCQs) were administered to
nurses on duty (excluding nurses in-charge) on the first day
of the visit. Questions included risk factors for ROP,
saturation limits for alarm settings on monitors, criteria
and timing of ROP screening according to RBSK guidelines [8]
and drops used to dilate pupils before screening (MCQs
available at https://figshare.com/articles/ROP_ annexure
/9757223/1). Most questions had been used by the National
ROP Task Force in an earlier gap analysis [6]; new questions
were validated by a neonatologist involved in ROP care.
On the second and third days, semi-structured interviews
to assess ROP – related attitudes and practices were
conducted with the ophthalmologist involved in ROP
screening, pediatrician in-charge, nurse in-charge and ROP
nurse. Questions covered their induction into and
perceptions of the program, challenges in the management of
ROP and suggestions for improvement. Topic guides for
interviews were developed (available at
https://figshare.com/articles/ROP_annexure/9757223/1), and
piloted before administration. Each participant provided
informed consent, and was assigned a unique code to maintain
confidentiality. On day three, equipment to deliver and
monitor oxygen were assessed and compared with national
guidelines [9]. Finally, medical records of infants
receiving oxygen at the time of the visit were reviewed for
documentation of oxygen saturation and frequency of
monitoring.
Ethical approval for the study was
obtained from the London School of Hygiene and Tropical
Medicine and Indian Institute of Public Health; permission
was obtained from the State National Health Mission. The
study adhered to the recommendations of Declaration of
Helsinki.
Statisticasl analyses: Qualitative data
were manually coded and analyzed thematically. Similarities
and differences in responses from different cadres and
centers were analyzed. Triangulation was provided by
observation of practices. Quantitative data were analyzed
for proportions, confidence intervals and Z test for
differences in proportions using STATA 2014. A P-value less
than 0.05 was considered statistically significant.
ResultsAll Newborn care corners
located in labor rooms or operating theatres had provision
to start oxygen but none had air-oxygen blenders and none
used pulse oximeters to monitor oxygen. Only SNCU A was able
to provide continuous positive airway pressure (CPAP).
All SNCU nurses had a bachelor qualification but their
number, according to SNCU guidelines [10], was adequate in
only one SNCU
(Table I). All SNCUs had more
than 100% occupancy, which staff considered to be the main
challenge in providing high-quality care (
Web
Table I). Only two SNCUs had enough pulse
oximeters to comply with the national guidelines [9], and
the number of functioning oximeters was 73% of that
recommended. Of the 14 infants where pulse oximeters were
being used, accurate alarms for lower limit of saturation
were set in 13, and upper limit only in one. Among the four
senior nurses interviewed, two stated that alarms were not
routinely set; another said only lower limits were set,
while the other said that alarms for both upper and lower
limits were set. Ophthalmologists interviewed admitted that
they did not focus on oxygen saturation while visiting
SNCUs.
Table I Equipment for Oxygen Delivery and Oxygen Monitoring Practices in Four Special Newborn Care Units (SNCU)
Characteristics |
Only ROP nurses sensitized |
All staff sensitized |
All SNCUs |
SNCU centre |
A |
B |
C |
D | |
Occupancy (bed strength) |
42 (30) |
27 (20) |
32 (27) |
28 (20) |
129 (97) |
Nurses , no. (recommended)* |
18 (25) |
15 (17) |
17 (22) |
20 (17) |
70 (81) |
Babies receiving oxygen at the time of visit |
12 |
2 |
3 |
1 |
18 |
Preterm infants receiving oxygen |
7 |
1 |
2 |
1 |
11 |
Blenders |
0 |
0 |
0 |
0 |
0 |
Equipment for CPAP |
Yes |
Yes |
Yes |
Yes | |
No. of pulse oximeters that should have been there# |
21 |
14 |
21 |
14 |
70 |
Adequate functioning pulse oximeters#, Yes/No (actual no.) |
No (8) |
No (3) |
Yes (24) |
Yes (16) |
51 |
Oxygen monitoring of all babies receiving oxygen | | | | | |
Pulse oximeters being used |
8 |
2 |
3 |
1 |
14 |
Upper alarms on |
0 |
0 |
1 (in CPAP) |
0 |
1 |
Upper limit set (target SpO2) |
0 |
0 |
1 (100) |
0 |
1 |
Number of lower alarms on (%) |
8 (67) |
1 (50) |
3 (100) |
1 (100) |
13 |
Correctly set lower limit alarms‡ (%) |
8 (100) |
1 (50) |
3 (100) |
1 (100) |
13 |
*As per ref. 10; #At least 14 per 20 beds recommended as per ref. 9; ‡88-89% SpO2 ; CPAP: Continuous positive airway pressure. |
In all SNCUs, none of the neonates receiving oxygen had
continuous saturation monitoring. Saturations had been
recorded in medical records for all babies receiving oxygen.
During interviews, three of the four neonatologists stated
that oxygen saturations were monitored every 1-2 hours,
whereas one acknowledged that continuous monitoring was only
provided for critical neonates. Among senior nurses, two
said that monitoring took place every two hours or according
to doctors’ instructions. One stated that all neonates
receiving oxygen received continuous monitoring whereas
another stated that this was only done for critically ill
neonates. The frequency of documentation varied from
two-hourly for critical to six-hourly for less critical
babies. Most cadres identified shortage of equipment and
poor maintenance as reasons for irregular monitoring
(Web Table I).
MCQs
were administered to 19 nurses (four each in SNCUs A and D,
five in B and six in C). In units C and D, nurses’ combined
score was 80.0% (95% CI, 68.7-88.6), which was significantly
higher than in units A and B (39.5%, 95% CI, 27.6-52.8%;
P<0.001). Overall, only 16% of answers to questions on upper
and lower oxygen saturation targets were correct; the three
nurses with correct answers worked in unit C. All the
pediatricians interviewed were aware of the appropriate
settings. Regarding gestational age and birthweight criteria
for ROP screening, none of the nurses in SCNUs A and B and 5
of 10 nurses in C and D answered correctly. All nurses knew
that preterm babies should be screened for ROP by 30 days
after birth.
Discussion Our
study found overcrowding, lack of adequate knowledge among
nurses, inadequate equipment, and inefficient use of
available equipment to be challenges in providing good
oxygen practices. Overcrowding, which was the main
challenge, leads to a relative shortage of nurses which can
compromise the quality of care [11]. Although all the
pediatricians knew the optimal target oxygen saturations,
these were known by only a few (16%) nurses, which may
explain why most alarms were not set or were incorrectly
set. A shortage of functioning pulse oximeters was a reason
given for lack of continuous oxygen saturation monitoring,
but two SNCUs were not continuously monitoring despite
having adequate oximeters. Despite existing International
recommen-dations [12], air-oxygen blenders were not
available in any newborn care corner or SNCU, making
delivery of 100% oxygen the only alternative. The higher MCQ
scores obtained by nurses in SNCUs C and D could be because
unlike in centers A and B, all the nurses involved in
patient-care had been included in ROP orientation sessions.
Since this study was planned as an early assessment
of the ROP program in India, many of the planned
interventions had not been implemented before the visits.
The findings are not, therefore, likely to reflect the full
impact of the interventions planned. The small number of
SNCUs covered by the program in the state, and low number of
infants receiving supplemental oxygen at the time of
observation may limit generalizability of findings. Further,
since MCQs were administered only once in each unit to avoid
contamination, the number of nurses assessed was limited.
In India, SNCU nurses undergo only short-term formal
training in neonatology and most training is in-service.
Previous studies have recommended training and sensitization
of nurses to improve practices [13,14] as nurses play an
important role in the prevention of ROP [4]. Similar
findings on inadequate personnel, equipment and
inconsistencies in knowledge of ROP have been observed in
Peru [15].
A ROP program supported by the Trust is
presently being implemented within the government health
system as a pilot, with a potential for national
scalability. Although the program has increased awareness
about ROP among healthcare professionals and provided ROP
services, our study highlights that better oxygen delivery
and saturation monitoring are required. Based on our
findings, we recommend making available positive pressure
air supply, oxygen blenders and one pulse oximeter per
infant [16] with spare probes in SNCUs. Repeated training
and sensitization of SNCU nurses to improve their knowledge
and use of equipment is also needed to reduce the incidence
of ROP, as has been reported in Peru [15]. Rational
admission policies to reduce overcrowding and an increase in
beds and staff could also improve practices. An assessment
of quality of care regarding oxygen administration is being
planned after all the quality improvement interventions have
been delivered, and data from this study will allow
comparisons to be made.
Acknowledgements: Prof GVS
Murthy, Director, Public Health Foundation of India, Dr
Rajan Shukla, Associate professor, IIPH and the team at
IIPH, Hyderabad for the support during this study.
Contributors: SS: conceptualized and designed the study,
designed the data collection instruments, collected data,
carried out the initial analyses, drafted the initial
manuscript and revised the manuscript; CG: conceptualized
and designed the study, supervised the designing of data
collection instrument and critically reviewed the manuscript
for important intellectual content; AF: supervised the
designing of the study and critically reviewed the
manuscript for important intellectual content; PK: provided
the inputs of the ongoing program, provided intellectual
content regarding neonatal care, supervised finalising the
data collection instrument and reviewed the manuscript. All
authors approved the final manuscript as submitted and agree
to be accountable for all aspects of the work.
Funding: Hooper Scholarship and LSHTM Trust Fund; Competing
interests: None stated.
What This Study Adds? |
• This mixed-method study
identified the limitations in the equipment and
deficiencies in practices of delivering and
monitoring oxygen in four Special newborn care units
in one state in India. |
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