Short Term Outcomes and Predictors of Mortality of Preterms Who Had Continuous Positive Airway Pressure Initiated at Delivery at in Urban Sub Saharan African Setting: A Retrospective Cohort Study

doi:10.21203/rs.3.rs-3991979/v1

Background

Continuous Positive Airway Pressure (CPAP) is a low-cost treatment modality for respiratory distress syndrome that has been shown to improve survival of preterm infants. However, its application at delivery is not routinely practiced in Uganda and Africa despite evidence from high income countries. Short term outcomes and predictors of mortality of preterm infants initiated on CPAP at Delivery at the St Francis hospital, Nsambya was reviewed in this study.

Methods

A retrospective cohort study was conducted at St Francis Hospital, Nsambya Neonatal Unit. Maternal and Neonatal records of Preterm infants that had CPAP initiated at delivery from January 2018 to December 2021 were reviewed. The proportion of preterm infants that survived to discharge were determined, those that required mechanical ventilation and surfactant replacement therapy. The predictors of mortality were determined using Cox proportionate hazard model. Kaplan Meier survival curve was used to determine survival probability.

Results

A total of 198 patient’s records were reviewed, the mean age of mother was 29 years and139 (70.2%) were delivered by cesarean section. 109 (55.1%) of the preterm infants were female, 146 (73.7%) survived to discharge.31 (15.7%) required mechanical ventilation and 38 (19.2%) received surfactant replacement therapy. The mean survival time was 42 days and predictors of mortality were gestation age less than 31 weeks, apnea of prematurity, pulmonary hemorrhage and APGAR score of less than 6 at 5 minutes.

Conclusions

The survival of preterm infants with respiratory distress was high when CPAP was initiated at delivery and small proportion required surfactant and mechanical ventilation. However, preterm infants delivered less than 31 weeks of gestation, having apnea of prematurity, pulmonary hemorrhage and an APGAR score less than 6 at 5 minutes had an increased the risk of mortality. Thus mortality of preterm infants that receive CPAP early can be reduced by intervening on the above predictors

CPAP at delivery

respiratory distress and mortality

Globally approximately 15 million preterm infants are born annually. Majority of them are in the middle and low income countries especially Southeast Asia and Sub-Saharan Africa (1). Preterm birth and its complications like respiratory distress syndrome are the leading causes of neonatal mortality (2). Continuous Positive Airway Pressure (CPAP) is a low-cost treatment modality for respiratory distress syndrome that has been shown to improve survival of preterm infants. When CPAP is initiated in the delivery room, it has been shown to reduce mortality of Preterm infants, reduce the need for mechanical ventilation, surfactant and reduce the rates of Bronchopulmonary dysplasia(3, 4). The Neonatal Resuscitation Program (NRP) added the consideration of CPAP for the all spontaneously breathing newborns with labored breathing, cyanosis and hypoxia to the resuscitation algorithm in 2010. This was during the update to 6th edition of NRP and this implied that CPAP could be started immediately after resuscitation within the delivery room (5). CPAP, when used in the delivery room causes early recruitment of alveoli, increases functional residual activity, decreases airway resistance, decreases thoraco-abdominal asynchrony and decreases intrapulmonary shunting leading to better oxygenation and ventilation (6). The studies done in low resource settings like in Africa have shown that labor room CPAP among preterm infants (< 34weeks) reduced the need for mechanical ventilation and surfactant replacement therapy by 36% and 56% respectively. This was following an assessment of a pre and post CPAP period (7).When CPAP in the delivery room was introduced as part of a quality improvement involving minimally invasive surfactant replacement therapy and delayed cord clamping the rates of mechanical ventilation in the delivery room, on admission and within the first 72 hours reduced and better respiratory outcomes for Preterm infants were observed (8). However, its application at delivery is not routinely practiced despite evidence from high income countries showing its benefits and recommending it. At St Francis hospital, Nsambya it had been practiced since 2018 but outcomes of preterm infants had not been assessed.

The study therefore aimed to determine the short-term outcomes and predictors of mortality of preterm infants that had CPAP initiated at delivery at St Francis hospital, Nsambya.

Study design and setting

A hospital based retrospective cohort study design was carried out from the neonatal Unit at St Francis Hospital, Nsambya. It is a tertiary, private and not for profit hospital in Kampala - the capital city of Uganda. The neonatal unit consists of a nursery (Baby unit) with 40 beds and a 10 bed Neonatal Intensive Care Unit. Health care in the neonatal units is provided by a Neonatologist, pediatricians, senior house officers, junior house officers and midwives. CPAP is preset up in the delivery rooms (labor ward and 2 operating theatres) and all preterm infants with signs of respiratory distress are initiated on CPAP after resuscitation. The CPAP is locally assembled using two low resistance tubes, bubble CPAP generator (fisher and Paykel), humidifier and ram cannula. The inspiratory tube is connected to the humidifier and oxygen source while the expiratory tube to the bubble CPAP generator. An infant resuscitator- Neopuff™ is used to provide CPAP in delivery room as well and during transport of preterm infants to the NICU.

Study participants

The study participants were maternal and neonatal records of all preterm infants that had CPAP initiated at delivery from 1st January 2018 to 31st December 2021 were retrieved from the records department and data on the progress of the neonate and maternal factors was extracted using an abstraction tool.

The inclusion criteria were all preterm infants that had CPAP initiated at delivery during study period and records of preterm infants that had missing outcome variable and severe congenital anomalies were excluded.

Sample size estimation

A sample size of 198 participants was calculated using a formula for survival analysis. n_events≥ \(\frac{{2({Z}_{1}+{Z}_{2})}^{2}}{({log}_{e}{HR)}^{2}}\)

Where Z_1−α/2 is the standard normal value corresponding to the level of significance (e.g., for a confidence level of 95%, α is 0.05 and the critical value is 1.96), Z_1−β is the standard normal value corresponding to the power of the study (e.g., for a power of 80%, β is 0.2 and the critical value is 0.84), log_e HR is the natural log of Hazard ratio for a given predictor variable. Using a study by Ermias Abebaw and colleagues on the incidence and predictors of mortality among preterm neonates in a NICU in Ethiopia(9). RDS was shown to be a significant predictor of mortality. Preterm infants with Respiratory distress syndrome were 1.49 times more likely to die compared to those without. (AHR = 1.49, 95%CI (1.03, 2.17)). The hazard ratio from this study was used to determine the number of participants needed.

Study variables

Dependent variable

Primary outcome: Survival to discharge and death.

Independent variables

Maternal factors which included age of the mother, attendance of antenatal care, complications during pregnancy and delivery, mode of delivery, type of pregnancy, Parity, use of antenatal corticosteroids, administration of magnesium sulphate, mothers and referral status, Neonatal factors which include APGAR score, birth weight, gestation age, complications during admission and diagnosis in the NICU.

Data sources

Before data collection, the data tool was prepared from existing literature. The questionnaire was pretested on 20 files and then the order and unclear questions were amended to ease data collection. Two trained research assistants with experience in collecting medical research data and the PI extracted the data.

Measurements

Outcome ascertainment

Primary outcome was survival to discharge or death. This was determined by reviewing the records and identifying the discharge or death summary.

Exposure ascertainment

The exposure was CPAP at delivery and this was determined by reviewing the records and being documented in the newborns chart.

Confounding ascertainment

Confounding was assessed and all variables that caused a ≥ 10% change in crude and adjusted models were considered confounders.

Data analysis

Data collected was entered into an electronic database using Epidata 4.2. The clean database was imported into STATA 15.1 for analysis. Continuous variables like age were summarized as means ± standard deviation or median (IQR). While categorical variables like sex were summarized in proportions, tables and graphs. The maternal and neonatal clinical characteristics were described and the proportion of those that survived to discharge following CPAP initiated in the delivery room determined. Bivariate analysis was done to determine the predictors of mortality. All factors with p-value < 0.2 were considered for multivariate analysis and p-value < 0.05 was considered statistically significant. A Cox Regression hazard model analysis was used to determine the predictors of mortality both at Bivariate and multivariate analysis. Kaplan Meier survival curves were used to determine probability of survival and long rank test computed.

A total of 198 participants were recruited in this study, the mean age and standard deviation (SD) of the neonates was 227±33 days while for the mothers was 29±5 years. The majority (n=109, 55.1%) of the neonates were female. The majority of the mothers (n=144, 72.7%) were low multiparous (1-3) and 157 (79.3%), singleton pregnancy and 139 (70.2%) were delivered by Caesarean section. (Table1). The majority of Preterm infants admitted were diagnosed with respiratory distress syndrome 77.3%, followed by Jaundice 61.6%, neonatal sepsis 61.1% and apnea of prematurity 15.7 %. (Table 2) None of the maternal demographic and clinical characteristics was statistically significant predictors of mortality at bivariate analysis but all those with p-value <0.2 were included in multivariate analysis. (Table 3) Gestation age less than 31weeks, Jaundice, Birth weight less than 1000g, Apnea, pulmonary haemorrhage, APGAR score at 5minutes, receiving mechanical ventilation, receiving surfactant and kangaroo care were statistically significant predictors of mortality at Bivariate analysis. (Table 4) The leading causes of death among preterm infants was neonatal sepsis followed by respiratory distress syndrome, pulmonary haemorrhage and apnea of prematurity. (Figure 1) The median survival time was 42 days and by day 10, the survival probability had reduced to 85.5% and 68.8% by day 14.(Figure 2)The Predictors of mortality were APGAR score less than 6 at 5 minutes (AHR=2.72, 95% CI: [1.18- 6.26]), apnea of prematurity (AHR=2.68, 95% CI: [1.34-5.35]), pulmonary haemorrhage (AHR=4.47, 95% CI: [1.43-14.0]) and gestation age 28-31 week and below <28 weeks (AHR=4.26, 95%CI: [1.97-9.23]) and. (AHR=9.29, 95% CI: [3.56-24.25]) respectively.(Table 5)

Table 1: Maternal demographic and clinical characteristics of Preterm infants who had CPAP initiated in the delivery room St Francis Hospital, Nsambya
Characteristic	Frequency (n)	Proportion (%)
Maternal age in years
19-24	51	25.8
25-34	119	60.1
35-45	28	14.1
Mother referred
No	161	81.3
Yes	37	18.7
Parity
Nulliparity	38	19.2
Low multiparity (1-3)	144	72.7
Grand multipara	16	8.1
ANC attendance
No	33	16.7
Yes	165	83.3
Type of pregnancy
Singleton	157	79.3
Triplets	9	4.5
Twins	32	16.2
Pregnancy complications
No	147	74.2
Yes	51	25.8
Mode of delivery
SVD	59	29.8
C-section	139	70.2
Received Antenatal corticosteroids
No	54	27.3
Yes	144	72.7
Received Magnesium sulphate
No	140	70.7
Yes	58	29.3
Had PPROM
No	142	71.7
Yes	56	28.3
Delivery complications
No	57	28.8
Yes	141	71.2

Table 2: Neonatal clinical characteristics of Preterm infants who had CPAP initiated in the delivery room St Francis Hospital, Nsambya
Characteristic	Frequency (n)	Proportion (%)
Neonatal age in weeks
31-36	135	68.2
28-31	36	18.2
<28	27	13.6
Sex
Female	109	55.1
Male	89	44.9
Birth weight in grams
>2500	37	18.7
1500-2499	95	47.9
1499-1000	35	17.7
<900	31	15.7
RDS
Absent	45	22.7
Present	153	77.3
Jaundice
Absent	76	38.4
Present	122	61.6
Sepsis
Absent	77	38.9
Present	121	61.1
Apnea of prematurity
Absent	168	84.8
Present	30	15.2
Pulmonary hemorrhage
Absent	185	93.4
Present	13	6.6
APGAR score at 5 minutes
7-10	160	80.8
4-6	38	19.2

Table 3: Bivariate analysis for maternal demographic and clinical characteristics as predictors of mortality of Preterm infants who had CPAP initiated in the delivery room at St Francis hospital, Nsambya
Characteristic	Alive, n(%)	Dead, n (%)	Crude HR [95%CI]	P-value
Maternal age in years
19-24	34 (66.7)	17 (33.3)	1.00
25-34	94 (79.0)	25 (21.0)	0.54[0.29-1.01]	0.053
35-45	18 (64.3)	10 (35.7)	1.11[0.50-2.45]	0.802
Mother referred
No	122 (75.8)	39 (24.2)	1.00
Yes	24 (64.9)	13 (35.1)	1.68[0.89-3.17]	0.112
Parity before birth
Nulliparity	23 (60.5)	15 (39.5)	1.00
Multiparity	112 (77.8)	32 (22.2)	0.63[0.34-1.18]	0.149
Grand multipara	11 (68.7)	5 (31.3)	0.87[0.31-2.42]	0.792
Antenatal attendance
No	21 (63.6)	12 (36.4)	1.00
Yes	125 (75.8)	40 (24.2)	0.52[0.27-1.01]	0.051
Type of pregnancy
Singleton	119 (75.8)	38 (24.2)	1.00
Triplets	6 (66.7)	3 (33.3)	0.70[0.21-2.32]	0.563
Twins	21 (65.6)	11 (34.4)	1.46[0.74-2.88]	0.274
Pregnancy complications
No	117 (79.6)	30 (20.4)	1.00
Yes	29 (56.9)	22 (43.1)	1.64[0.93-2.87]	0.086
Mode of delivery
SVD	43 (72.9)	16 (27.1)	1.00
C-section	103 (74.1)	36 (25.9)	1.25[0.69-2.26]	0.466
Received Antenatal corticosteroids
No	33 (61.1)	21 (38.9)	1.00
Yes	113 (78.5)	31 (21.5)	0.58[0.33-1.02]	0.068
Received Magnesium sulphate
No	110 (78.6)	30 (21.4)	1.00
Yes	36 (62.1)	22 (37.9)	1.51[0.86-2.62]	0.148
Had PPROM
No	107 (75.3)	35 (24.7)	1.00
Yes	39 (69.6)	17 (30.4)	1.13[0.63-2.04]	0.683
Delivery complications
No	44 (77.2)	13 (22.8)	1.00
Yes	102 (72.3)	39 (27.7)	1.71[0.89-3.30]	0.109

Table 4: Bivariate analysis of demographic and clinical characteristics of Preterm infants that had CPAP initiated at delivery
Characteristic	Alive, n (%)	Dead, n (%)	Crude HR [95%CI]	P-value
Gestation age in weeks
31-36	122 (90.4)	13 (9.6)	1.00
28-31	19 (52.8)	17 (47.2)	3.99[1.88-8.47]	<0.001
<28	5 (18.5)	22 (81.5)	8.25[4.04-16.85]	<0.001
Sex
Female	79 (72.5)	30 (27.5)	1.00
Male	67 (72.3)	22 (24.7)	1.01[0.58-1.76]	0.965
Birth weight
≥2500g	34 (91.9)	3 (8.1)	1.00
<2500g	83 (87.4)	12 (12.6)	1.80[0.50-6.43]	0.368
<1500g	25 (71.4)	10 (28.6)	2.53[0.67-9.49]	0.170
<1000g	4 (12.9)	27 (87.1)	12.16[3.56-41.54]	<0.001
RDS
Absent	35 (77.8)	10 (22.2)	1.00
Present	111 (72.5)	42 (27.5)	1.72[0.81-3.63]	0.155
Jaundice
Absent	42 (55.3)	34 (44.7)	1.00
Present	104 (85.3)	18 (14.7)	0.27[0.15-0.50]	<0.001
Sepsis
Absent	63 (81.8)	14 (18.1)	1.00
Present	83 (68.6)	38 (31.4)	1.50[0.81-2.78]	0.194
Apnoea of prematurity
Absent	135 (80.4)	33 (19.6)	1.00
Present	11 (36.7)	19 (63.3)	2.63[1.48-4.66]	0.001
Pulmonary haemorrhage
Absent	145 (78.9)	39 (21.1)	1.00
Present	1(7.1)	13 (92.9)	5.92[3.12-11.22]	<0.001
APGAR score at 5 minutes
7-10	131 (81.9)	29 (18.1)	1.00
4-6	15 (39.5)	23 (60.5)	3.63[2.08-6.34]	<0.001

Table 5: Multivariate analysis of predictors of mortality of Preterm infants who had CPAP initiated in the delivery room at St Francis hospital, Nsambya from 2018-2021
Characteristic	Crude HR [95%CI]	Adjusted HR [95%CI]	P-value
Gestation age
>31	1.00	1.00
28-31	3.99[1.88-8.47]	4.26[1.97-9.23]	<0.001
<28	8.25[4.04-16.85]	9.29[3.56-24.25]	<0.001
Maternal age
19-24	1.00	1.00
25-34	0.54[0.29-1.01]	0.42[0.19-0.93]	0.032
35-45	1.11[0.50-2.45]	0.65[0.26-1.63]	0.355
Mother referred
No	1.00	1.00
Yes	1.68[0.89-3.17]	0.31[0.13-0.76]	0.010
Jaundice
Absent	1.00	1.00
Present	0.27[0.15-0.50]	0.30[0.16-0.57]	<0.001
Apnea of prematurity
Absent	1.00	1.00
Present	2.63[1.48-4.66]	2.68[1.34-5.35]	0.005
Pulmonary hemorrhage
Absent	1.00	1.00
Present	5.92[3.12-11.22]	4.47[1.43-14.00]	0.010
APGAR score at 5 minutes
7-10	1.00	1.00
4-6	3.63[2.08-6.34]	2.72[1.18-6.26]	0.019

A review of charts was conducted for preterm infants that received CPAP at delivery and determined the proportion of preterm infants that survived to discharge and predictors of mortality. 146 (73.7%) survived to discharge. From this study majority of preterm infants survived to discharge which is in keeping with findings from high income countries(10). CPAP should be started at delivery as recommended by the European consensus guidelines on management of RDS in the delivery room in our settings (11).

Preterm infants with apnea of prematurity had 2.63 times higher risk of death. Apnea is associated with bradycardia and hypoxia which increases risk of mortality (12). Mortality from apnea may have been increased by the presence of other factors like PDA, sepsis, intraventricular hemorrhage, anemia. No studies in our setting have determined the effect of CPAP at delivery apnea. However CPAP is used to treat obstructive apnea in preterm in neonates (13).

Pulmonary hemorrhage significantly increased the risk of mortality of Preterm infants that had CPAP at delivery (AHR = 4.47 95% CI 1.43–5.35) Pulmonary hemorrhage may have been due to PDA, or coagulopathy which are known causes of death among preterm infants. All babies that developed pulmonary hemorrhage died a finding similar to a study by Kaasif et al (Year)(14).

Preterm infants with APGAR score less than 6 at 5minutes had a high risk of mortality (AHR = 2.75 95% CI 18.6–6.26). These had asphyxia at birth which could have increased the risk of harmful complication such as respiratory distress, pulmonary hemorrhage, intraventricular hemorrhage and sepsis. The findings are similar to those in other studies which found a high risk of mortality among preterm infants that had low APGAR at 5 minutes(15, 16).

Gestation age less than 31 weeks was a significant predictor of mortality among preterm infants that had CPAP at delivery; this may have been due to complications associated with prematurity. Prematurity was found a significant risk factor for mortality in studies done in Africa.(17, 18)

However, Preterm infants with Jaundice had a 70% higher chance of survival; this may have been due to adherence to treatment guidelines and were more likely to be investigated for other cause of morbidity and mortality. These findings were contrary to those from another study that found a 1.65 times higher risk of mortality among newborns with jaundice(19). However, similar findings from a study done in the same settings that found jaundice a common morbidity but no preterm died from jaundice (20). Jaundice has been demonstrated to have antioxidant properties in animal studies at low level and this could have been one of the reasons why it’s not associated with increased mortality however our study did not seek to find this effect(21). Preterm infants whose mothers were referred had a 69% higher chance of survival compared to those that were not and this was attributed to the care provided and preparation done for these premature infants.

The limitation of the study was being a retrospective and could have missed out on some confounders. It was carried out in tertiary hospital and findings may not be generalizable to lower facilities. The authors recommend a prospective study or a before and after study, screening for PDA and coagulopathy in preterm infants that are at risk and aggressive treatment for apnea of prematurity.

Despite the improved respiratory outcomes among preterm infants that receive CPAP at delivery, there are other factors that could increase the risk of mortality. This is concerning for care providers that consider CPAP at delivery a live saving intervention. Thus, it is important to identify factors and co morbidities that would increase risk of mortality such as gestation age less than 31 weeks, APGAR score less than 6 at 5minutes, apnea of prematurity and pulmonary hemorrhage. Our findings demonstrated that a preterm that receives CPAP at delivery and is below 31 weeks or had an APGAR less than 6 at 5 minutes requires close monitoring. Our findings also demonstrate the need prophylaxis or aggressive treatment for apnea and screening for and prompt management for pulmonary hemorrhage will further reduce mortality among this group.

The strength of the study is that it’s among the few studies in Uganda and Africa on CPAP at delivery.

AOP: Apnea of Prematurity; APGAR: Appearance, Pulse, Grimace, Activity, Respiration, APH: Antepartum Hemorrhage; CPAP: Continuous Positive Airway Pressure; ENAP: Every Newborn Action Plan; HIE: Hypoxic Ischemic Encephalopathy; HIV: Human Immunodeficiency Virus; HMD: Hyaline Membrane Disease; NICU: Neonatal Intensive Care Unit; NRP: Neonatal Resuscitation Program; PPROM: Preterm Premature Rupture of Membranes; RDS: Respiratory Distress Syndrome; SVD: Spontaneous Vagina Delivery;

Ethical approval and consent to participate

This study was approved by the St Francis Hospital, Nsambya Research and ethics committee: Informed Consent to carry out the study was waived, however permission to access medical records was granted by the hospital administration

Consent for publication:

Not applicable

Availability of data and materials

Competing interests

Authors declare no competing interests

Funding

This study was sponsored by the St Francis Hospital, Nsambya and some funds were contributed by the author

Author Details

²Department of Pediatrics and Child health St Francis Hospital, Nsambya Kampala- Uganda, ⁴Mulago National referral Hospital, Department of Pediatrics of Child Health Makerere college of health Sciences Kampala- Uganda Kampala-Uganda, ¹Uganda Martyrs University-Mother Kevin Post Graduate Medical School, ³Mulago National Referral Hospital.

Authors Contributions

BP, ME, NV contributed in designing the proposal, BP,ME, GE contributed in the writing and editing the paper, all authors have read and approved the manuscript

Supplementary information:

Acknowledgement:

We would like to thank the department of Pediatrics and child health and records at St Francis Hospital, Nsambya for providing the access to the data we used in this study. Additionally, we are thankful to the mothers and preterm infants whose information we used for the study.

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No competing interests reported.

Short Term Outcomes and Predictors of Mortality of Preterms Who Had Continuous Positive Airway Pressure Initiated at Delivery at in Urban Sub Saharan African Setting: A Retrospective Cohort Study

Status:

Version 1

Abstract

Figures

BACKGROUND

METHODS

Study design and setting

Study participants

Sample size estimation

Study variables

Dependent variable

Independent variables

Data sources

Measurements

Outcome ascertainment

Exposure ascertainment

Confounding ascertainment

Data analysis

RESULTS

DISCUSSION

CONCLUSIONS

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1