Comparative Study Randomized Controlled Trial

Authors: , Sugandha Arya, Helga Naburi...

BACKGROUND

"Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain.

METHODS

We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life.

RESULTS

A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care.

CONCLUSIONS

Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

Topics: Africa South of the Sahara; Breast Feeding; Developing Countries; Female; Humans; Incubators, Infant; India; Infant; Infant Mortality; Infant, Low Birth Weight; Infant, Newborn; Intensive Care Units, Neonatal; Kangaroo-Mother Care Method; Male; Time Factors

PubMed: 34038632
DOI: 10.1056/NEJMoa2026486

Review

Authors: Christoph Härtel, Angela Kribs, Wolfgang Göpel...

BACKGROUND

Less invasive surfactant administration (LISA) has become the preferred method of surfactant administration for spontaneously breathing babies on continuous positive airway pressure (CPAP).

SUMMARY

The development of LISA followed the need to combine CPAP and surfactant replacement as mainstay treatment options for respiratory distress syndrome, thereby avoided exposure to positive pressure ventilation.

KEY MESSAGES

This review summarises the current knowns and unknowns of LISA including the physiological concept, its relevance for short-term and long-term outcomes and the challenges for practical implementation of LISA as part of a less invasive respiratory care bundle. Further, we provide an update of the evidence on alternatives to LISA, for example, nebulised surfactant administration, pharyngeal deposition of surfactant and delivery via supraglottic airway.

Topics: Humans; Pulmonary Surfactants; Infant, Newborn; Respiratory Distress Syndrome, Newborn; Infant, Premature; Continuous Positive Airway Pressure; Administration, Inhalation; Nebulizers and Vaporizers

PubMed: 39226881
DOI: 10.1159/000540078

Meta-Analysis

Authors: Abdulraoof Almadhoob, Arne Ohlsson

BACKGROUND

Infants in the neonatal intensive care unit (NICU) are subjected to stress, including sound of high intensity. The sound environment in the NICU is louder than most home or office environments and contains disturbing noises of short duration and at irregular intervals. There are competing auditory signals that frequently challenge preterm infants, staff and parents. The sound levels in NICUs often exceed the maximum acceptable level of 45 decibels (dB), recommended by the American Academy of Pediatrics. Hearing impairment is diagnosed in 2% to 10% of preterm infants versus 0.1% of the general paediatric population. Noise may cause apnoea, hypoxaemia, alternation in oxygen saturation, and increased oxygen consumption secondary to elevated heart and respiratory rates and may, therefore, decrease the amount of calories available for growth. Elevated levels of speech are needed to overcome the noisy environment in the NICU, thereby increasing the negative impacts on staff, newborns, and their families. High noise levels are associated with an increased rate of errors and accidents, leading to decreased performance among staff. The aim of interventions included in this review is to reduce sound levels to 45 dB or less. This can be achieved by lowering the sound levels in an entire unit, treating the infant in a section of a NICU, in a 'private' room, or in incubators in which the sound levels are controlled, or reducing the sound levels that reaches the individual infant by using earmuffs or earplugs. By lowering the sound levels that reach the neonate, the resulting stress on the cardiovascular, respiratory, neurological, and endocrine systems can be diminished, thereby promoting growth and reducing adverse neonatal outcomes.

OBJECTIVES

Primary objective To determine the effects of sound reduction on growth and long-term neurodevelopmental outcomes of neonates. Secondary objectives 1. To evaluate the effects of sound reduction on short-term medical outcomes (bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity). 2. To evaluate the effects of sound reduction on sleep patterns at three months of age. 3. To evaluate the effects of sound reduction on staff performance. 4. To evaluate the effects of sound reduction in the neonatal intensive care unit (NICU) on parents' satisfaction with the care.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE, EMBASE, CINAHL, abstracts from scientific meetings, clinical trials registries (clinicaltrials.gov; controlled-trials.com; and who.int/ictrp), Pediatric Academic Societies Annual meetings 2000 to 2014 (Abstracts2View), reference lists of identified trials, and reviews to November 2014.

SELECTION CRITERIA

Preterm infants (< 32 weeks' postmenstrual age (PMA) or < 1500 g birth weight) cared for in the resuscitation area, during transport, or once admitted to a NICU or a stepdown unit.

DATA COLLECTION AND ANALYSIS

We performed data collection and analyses according to the Cochrane Neonatal Review Group.

MAIN RESULTS

One small, high quality study assessing the effects of silicone earplugs versus no earplugs qualified for inclusion. The original inclusion criteria in our protocol stipulated an age of < 48 hours at the time of initiating sound reduction. We made a deviation from our protocol and included this study in which some infants would have been > 48 hours old. There was no significant difference in weight at 34 weeks postmenstrual age (PMA): mean difference (MD) 111 g (95% confidence interval (CI) -151 to 374 g) (n = 23). There was no significant difference in weight at 18 to 22 months corrected age between the groups: MD 0.31 kg, 95% CI -1.53 to 2.16 kg (n = 14). There was a significant difference in Mental Developmental Index (Bayley II) favouring the silicone earplugs group at 18 to 22 months corrected age: MD 14.00, 95% CI 3.13 to 24.87 (n = 12), but not for Psychomotor Development Index (Bayley II) at 18 to 22 months corrected age: MD -2.16, 95% CI -18.44 to 14.12 (n =12).

AUTHORS' CONCLUSIONS

To date, only 34 infants have been enrolled in a randomised controlled trial (RCT) testing the effectiveness of reducing sound levels that reach the infants' ears in the NICU. Based on the small sample size of this single trial, we cannot make any recommendations for clinical practice. Larger, well designed, conducted and reported trials are needed.

Topics: Ear Protective Devices; Employee Performance Appraisal; Health Personnel; Humans; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Intensive Care Units, Neonatal; Noise; Randomized Controlled Trials as Topic; Sound; Stress, Physiological

PubMed: 31986231
DOI: 10.1002/14651858.CD010333.pub3

Randomized Controlled Trial

Authors: Laila Kristoffersen, Ragnhild Støen, Hilde Rygh...

BACKGROUND

Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at St. Olav's University Hospital. In the present study we aim to investigate whether skin-to-skin care following delivery is safe, and how it affects early and late outcomes compared to standard care for very preterm infants.

METHODS/DESIGN

A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 28-31 weeks with birth weight >1000 grams. Infants with severe congenital malformations or need of intubation in the delivery room are excluded. A detailed checklist and a flowchart were prepared for the study, and all involved professionals (neonatologists, neonatal nurses, obstetricians, anesthesiologists, midwives) participated in medical simulation training prior to study start on February 1, 2014. A consultant in neonatology and a neonatal nurse are present at all deliveries. Infants with birth weight <1500 grams receive an intravenous line with glucose, amino acids, and caffeine citrate in the delivery room. Infants with gestational age <30 weeks are routinely put on continuous positive airway pressure (CPAP). After initial stabilization, infants are randomized to skin-to-skin care or are transferred to the nursery in an incubator. Primary outcome is cognitive development at 2 years measured with the Bayley Scales of Infant Development, Third Edition. Secondary outcomes are safety defined as hypothermia, respiratory failure, and/or cardiopulmonary resuscitation, physiological stability after birth and motor, language and cognitive development at 1 year for the child, and mental health measured with the State-Trait Anxiety Inventory (STAI) at discharge, and at 3 months and 2 years after expected date of delivery for the mothers.

DISCUSSION

The study may have important implications for the initial care for very preterm infants after delivery and increase our understanding of how early skin-to-skin care affects preterm infants and their mothers.

TRIAL REGISTRATION

ClinicalTrials, NCT02024854 . Registered on 19 December 2013.

Topics: Birth Weight; Checklist; Child Development; Child, Preschool; Clinical Protocols; Gestational Age; Humans; Incubators, Infant; Infant; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Intensive Care Units, Neonatal; Kangaroo-Mother Care Method; Mother-Child Relations; Norway; Object Attachment; Research Design; Skin Physiological Phenomena; Time Factors; Workflow

PubMed: 27955652
DOI: 10.1186/s13063-016-1730-5

Review

Authors: Matthew J Barkovich, Yi Li, Rahul S Desikan...

Pediatric neuroimaging is challenging due the rapid structural, metabolic, and functional changes that occur in the developing brain. A specially trained team is needed to produce high quality diagnostic images in children, due to their small physical size and immaturity. Patient motion, cooperation and medical condition dictate the methods and equipment used. A customized approach tailored to each child's age and functional status with the appropriate combination of dedicated staff, imaging hardware, and software is key; these range from low-tech techniques, such as feed and swaddle, to specialized small bore MRI scanners, MRI compatible incubators and neonatal head coils. New pre-and post-processing techniques can also compensate for the motion artifacts and low signal that often degrade neonatal scans.

Topics: Brain; Child; Female; Humans; Infant; Infant, Newborn; Male; Neuroimaging

PubMed: 29684645
DOI: 10.1016/j.neuroimage.2018.04.044

Meta-Analysis Review

Authors: Greta Sibrecht, Katarzyna Wróblewska-Seniuk, Matteo Bruschettini...

BACKGROUND

Infants in the neonatal intensive care unit (NICU) are subjected to different types of stress, including sounds of high intensity. The sound levels in NICUs often exceed the maximum acceptable level recommended by the American Academy of Pediatrics, which is 45 decibels (dB). Hearing impairment is diagnosed in 2% to 10% of preterm infants compared to only 0.1% of the general paediatric population. Bringing sound levels under 45 dB can be achieved by lowering the sound levels in an entire unit; by treating the infant in a section of a NICU, in a 'private' room, or in incubators in which the sound levels are controlled; or by reducing sound levels at the individual level using earmuffs or earplugs. By lowering sound levels, the resulting stress can be diminished, thereby promoting growth and reducing adverse neonatal outcomes. This review is an update of one originally published in 2015 and first updated in 2020.

OBJECTIVES

To determine the benefits and harms of sound reduction on the growth and long-term neurodevelopmental outcomes of neonates.

SEARCH METHODS

We used standard, extensive Cochrane search methods. On 21 and 22 August 2023, a Cochrane Information Specialist searched CENTRAL, PubMed, Embase, two other databases, two trials registers, and grey literature via Google Scholar and conference abstracts from Pediatric Academic Societies.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) or quasi-RCTs in preterm infants (less than 32 weeks' postmenstrual age (PMA) or less than 1500 g birth weight) cared for in the resuscitation area, during transport, or once admitted to a NICU or stepdown unit. We specified three types of intervention: 1) intervention at the unit level (i.e. the entire neonatal department), 2) at the section or room level, or 3) at the individual level (e.g. hearing protection).

DATA COLLECTION AND ANALYSIS

We used the standardised review methods of Cochrane Neonatal to assess the risk of bias in the studies. We used the risk ratio (RR) and risk difference (RD), with their 95% confidence intervals (CIs), for dichotomous data. We used the mean difference (MD) for continuous data. Our primary outcome was major neurodevelopmental disability. We used GRADE to assess the certainty of the evidence.

MAIN RESULTS

We included one RCT, which enroled 34 newborn infants randomised to the use of silicone earplugs versus no earplugs for hearing protection. It was a single-centre study conducted at the University of Texas Medical School in Houston, Texas, USA. Earplugs were positioned at the time of randomisation and worn continuously until the infants were 35 weeks' postmenstrual age (PMA) or discharged (whichever came first). Newborns in the control group received standard care. The evidence is very uncertain about the effects of silicone earplugs on the following outcomes. • Cerebral palsy (RR 3.00, 95% CI 0.15 to 61.74)and Mental Developmental Index (MDI) (Bayley II) at 18 to 22 months' corrected age (MD 14.00, 95% CI 3.13 to 24.87); no other indicators of major neurodevelopmental disability were reported. • Normal auditory functioning at discharge (RR 1.65, 95% CI 0.93 to 2.94) • All-cause mortality during hospital stay (RR 2.07, 95% CI 0.64 to 6.70; RD 0.20, 95% CI -0.09 to 0.50) • Weight (kg) at 18 to 22 months' corrected age (MD 0.31, 95% CI -1.53 to 2.16) • Height (cm) at 18 to 22 months' corrected age (MD 2.70, 95% CI -3.13 to 8.53) • Days of assisted ventilation (MD -1.44, 95% CI -23.29 to 20.41) • Days of initial hospitalisation (MD 1.36, 95% CI -31.03 to 33.75) For all outcomes, we judged the certainty of evidence as very low. We identified one ongoing RCT that will compare the effects of reduced noise levels and cycled light on visual and neural development in preterm infants.

AUTHORS' CONCLUSIONS

No studies evaluated interventions to reduce sound levels below 45 dB across the whole neonatal unit or in a room within it. We found only one study that evaluated the benefits of sound reduction in the neonatal intensive care unit for hearing protection in preterm infants. The study compared the use of silicone earplugs versus no earplugs in newborns of very low birth weight (less than 1500 g). Considering the very small sample size, imprecise results, and high risk of attrition bias, the evidence based on this research is very uncertain and no conclusions can be drawn. As there is a lack of evidence to inform healthcare or policy decisions, large, well designed, well conducted, and fully reported RCTs that analyse different aspects of noise reduction in NICUs are needed. They should report both short- and long-term outcomes.

Topics: Humans; Infant, Newborn; Intensive Care Units, Neonatal; Infant, Premature; Noise; Infant, Very Low Birth Weight; Randomized Controlled Trials as Topic; Sound; Ear Protective Devices; Bias; Hearing Loss, Noise-Induced

PubMed: 38813836
DOI: 10.1002/14651858.CD010333.pub4

Review

Authors: Noorul Husna Abd Rahman, Ayman Khallel Ibrahim, Khairunnisa Hasikin...

Medical device reliability is the ability of medical devices to endure functioning and is indispensable to ensure service delivery to patients. Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) technique was employed in May 2021 to evaluate existing reporting guidelines on medical device reliability. The systematic searching is conducted in eight different databases, including Web of Science, Science Direct, Scopus, IEEE Explorer, Emerald, MEDLINE Complete, Dimensions, and Springer Link, with 36 articles shortlisted from the year 2010 to May 2021. This study aims to epitomize existing literature on medical device reliability, scrutinize existing literature outcomes, investigate parameters affecting medical device reliability, and determine the scientific research gaps. The result of the systematic review listed three main topics on medical device reliability: risk management, performance prediction using Artificial Intelligence or machine learning, and management system. The medical device reliability assessment challenges are inadequate maintenance cost data, determining significant input parameter selection, difficulties accessing healthcare facilities, and limited age in service. Medical device systems are interconnected and interoperating, which increases complexity in assessing their reliability. To the best of our knowledge, although machine learning has become popular in predicting medical device performance, the existing models are only applicable to selected devices such as infant incubators, syringe pumps, and defibrillators. Despite the importance of medical device reliability assessment, there is no explicit protocol and predictive model to anticipate the situation. The problem worsens with the unavailability of a comprehensive assessment strategy for critical medical devices. Therefore, this study reviews the current state of critical device reliability in healthcare facilities. The present knowledge can be improved by adding new scientific data emphasis on critical medical devices used in healthcare services.

Topics: Infant; Humans; Artificial Intelligence; Reproducibility of Results; Health Services; Health Facilities; Delivery of Health Care

PubMed: 36860328
DOI: 10.1155/2023/3136511

Review

Authors: Shannon Tocchio, Beth Kline-Fath, Emanuel Kanal...

Magnetic resonance imaging (MRI) evaluation of the developing brain has dramatically increased over the last decade. Faster acquisitions and the development of advanced MRI sequences, such as magnetic resonance spectroscopy (MRS), diffusion tensor imaging (DTI), perfusion imaging, functional MR imaging (fMRI), and susceptibility-weighted imaging (SWI), as well as the use of higher magnetic field strengths has made MRI an invaluable tool for detailed evaluation of the developing brain. This article will provide an overview of the use and challenges associated with 1.5-T and 3-T static magnetic fields for evaluation of the developing brain. This review will also summarize the advantages, clinical challenges, and safety concerns specifically related to MRI in the fetus and newborn, including the implications of increased magnetic field strength, logistics related to transporting and monitoring of neonates during scanning, and sedation considerations, and a discussion of current technologies such as MRI conditional neonatal incubators and dedicated small-foot print neonatal intensive care unit (NICU) scanners.

Topics: Brain; Diffusion Magnetic Resonance Imaging; Equipment Design; Humans; Incubators, Infant; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Intensive Care Units, Neonatal; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Neuroimaging; Signal-To-Noise Ratio

PubMed: 25743582
DOI: 10.1053/j.semperi.2015.01.002

Review

Authors: V Sashi Kumar, V K Paul, K Sathasivam...

The care of small and sick neonates requires biomedical technologies, such as devices that can keep babies warm (radiant warmers and incubators), resuscitate (self-inflating bags), track growth (weighing scales), treat jaundice (phototherapy units) and provide oxygen or respiratory support (hoods, continuous positive airway pressure (CPAP) devices and ventilators). Until the 1990s, most of these products were procured through import at a high cost and with little maintenance support. Emerging demand and an informal collaboration of neonatologists, engineers and entrepreneurs has led to the production of good quality equipment of several high-volume categories at affordable cost in India. Radiant warmers, resuscitation bags, phototherapy units, weighing scales and other devices manufactured by Indian small-scale companies have enabled an expansion of neonatal care in the country, particularly in district hospitals, medical college hospitals and subdistrict facilities in the public sector as a part of the National Rural Health Mission. Indian products have acquired international quality standards and are even exported to developed nations. This paper captures this story of innovation and entrepreneurship in neonatal care.

Topics: Delivery of Health Care; Equipment and Supplies, Hospital; Humans; India; Infant; Infant Care; Infant, Newborn; Intensive Care, Neonatal; Neonatology; Outcome Assessment, Health Care

PubMed: 27924105
DOI: 10.1038/jp.2016.188

Review

Authors: Maria de Fátima Hasek Nogueira, Karina Chamma Di Piero, Eloane Gonçalves Ramos...

This systematic literature review evaluated the methodological quality of studies measuring noise in neonatal intensive care units. A manual and also electronic search in the Medline, Scielo, Lilacs, BDENF, WHOLIS, BDTD, Science Direct, NCBI and Scirus databases resulted in 40 studies that met the criterion "measuring noise in neonatal units and/or incubators". Experts in neonatology and acoustics validated the critical analysis instrument, which obtained a mean = 7.9 (SD=1.3). The inter-observer reliability in 18 articles resulted in an Intra-class correlation coefficient (ICC) of 0.89 (CI 0.75-0.95). The quality indicators were 50% better in those studies that measured noise only in the unit's environment and associated measuring strategies to the physical area. The results showed great methodological variability, which hindered comparability and raised the probability of bias. The conditions required to ensure internal and external validity were observed in few studies.

Topics: Humans; Incubators, Infant; Infant, Newborn; Intensive Care Units, Neonatal; Noise

PubMed: 21412649
DOI: 10.1590/s0104-11692011000100028