Influence of Ear Protectors on the Sleep of Preterm Newborns: A Randomized Controlled Clinical Study

The purpose of this study was to compare the effect of ear protectors on the sleep of preterm newborns during the “quiet” times in intermediate care nursery. This was a clinical, randomized, controlled crossover study conducted in two neonatal units in São Paulo, Brazil. The sample consisted of preterm infants who met the inclusion and exclusion criteria for the study. Polysomnography and unstructured observation were used for data collection. Twenty-four preterm infants with a mean gestational age of 33.2 weeks and current weight of 1.747 g were analyzed. There was no significant difference in the total sleep time of preterm infants with and without the use of ear protectors. Newborns with lower gestational age showed a significant reduction in total sleep time with the use of ear protectors ( p < .05). The use of ear protection did not increase the total sleep time for preterm infants.

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Sleep and salivary cortisol in preterm neonates: a clinical, randomized, controlled, crossover study

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2017-0546 ◽

2018 ◽

Vol 71 (suppl 3) ◽

pp. 1358-1365

Author(s):

Fabrícia Magalhães Araújo ◽

Mavilde da Luz Gonçalves Pedreira ◽

Ariane Ferreira Machado Avelar ◽

Márcia Lurdes de Cácia Pradella-Hallinan ◽

Miriam Harumi Tsunemi ◽

...

Keyword(s):

Crossover Study ◽

Salivary Cortisol ◽

Total Sleep Time ◽

Statistical Significance ◽

Sleep Time ◽

Preterm Neonates ◽

Randomized Controlled ◽

Significant Difference ◽

Salivary Cortisol Level ◽

Baseline Levels

ABSTRACT Objective: Analyze the influence of ear protectors on the baseline levels of salivary cortisol and response and total sleep time of preterm neonates during two periods of environmental management of a neonatal intermediate care unit. Method: A clinical, randomized, controlled and crossover study conducted with 12 preterm neonates. The use of ear protectors was randomized in two periods. Sleep evaluation was performed using one Alice 5 Polysomnography System and unstructured observation. Results: No significant difference was observed between the baseline levels of salivary cortisol and response in preterm neonates from the control and experimental groups, and no statistical significance was observed between the total sleep time of both groups. No relationship was observed between the baseline levels of cortisol and response and total sleep time. Conclusion: Ear protectors in preterm neonates did not influence the salivary cortisol level and total sleep time in the studied periods.

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The Timing of Initiating Complementary Feeding in Preterm Infants and Its Effect on Overweight: A Systematic Review

Annals of Nutrition and Metabolism ◽

10.1159/000488732 ◽

2018 ◽

Vol 72 (4) ◽

pp. 307-315 ◽

Cited By ~ 8

Author(s):

Karin M. Vissers ◽

Edith J.M. Feskens ◽

Johannes B. van Goudoever ◽

Arieke J. Janse

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Preterm Infants ◽

Complementary Feeding ◽

Controlled Trial ◽

Controlled Trials ◽

Z Score ◽

Term Infants ◽

Randomized Controlled ◽

Significant Difference

Background: What is the appropriate time to start complementary feeding for preterm infants? The answer to this question is yet under debate. The timing of initiating complementary feeding may be associated with overweight in term infants. This systematic review aimed to study the effect of the timing of initiating complementary feeding on overweight in preterm infants. Predefined search items included preterm infants, complementary feeding, overweight, and their synonyms. Summary: The search identified 15,749 articles, of which 5 articles were included. Three studies presented data of randomized controlled trials and 2 studies were cohort studies. Two randomized controlled trials found no significant difference in body mass index (BMI) Z-score between the intervention groups at 12 months of age. One randomized controlled trial presented a significant greater mean rate of growth in length per week until 12 months in the preterm weaning strategy-group compared with the current best practices. One observational study concluded that each month the infants received complementary food later, the Z-score for length and weight was reduced by 0.1. Key Messages: No clear conclusion could be drawn from the included studies. This review illustrates the need for further research to access the effect of the timing of initiating complementary feeding on overweight in preterm infants.

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Mediating role of screen media use on adolescents' total sleep time: A cluster‐randomized controlled trial for physical activity and sedentary behaviour

Child Care Health and Development ◽

10.1111/cch.12755 ◽

2020 ◽

Vol 46 (3) ◽

pp. 381-389

Author(s):

Margarethe Thaisi Garro Knebel ◽

Adriano Ferreti Borgatto ◽

Marcus Vinicius Veber Lopes ◽

Priscila Cristina Santos ◽

Thiago Sousa Matias ◽

...

Keyword(s):

Physical Activity ◽

Total Sleep Time ◽

Controlled Trial ◽

Sleep Time ◽

Mediating Role ◽

Screen Media ◽

Randomized Controlled ◽

Screen Media Use ◽

Cluster Randomized

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Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial

Physical Therapy ◽

10.1093/ptj/pzz120 ◽

2019 ◽

Vol 99 (12) ◽

pp. 1690-1702 ◽

Cited By ~ 1

Author(s):

Yen-Ting Yu ◽

Wan-Chi Huang ◽

Wu-Shiun Hsieh ◽

Jui-Hsing Chang ◽

Chyi-Her Lin ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Preterm Infants ◽

Gestational Age ◽

Controlled Trial ◽

Randomized Controlled ◽

Oddball Task ◽

Appropriate For Gestational Age ◽

Related Potentials ◽

Family Centered

Abstract Background Family-centered intervention for preterm infants has shown short- to medium-term developmental benefits; however, the neurological effects of intervention have rarely been explored. Objective The objectives of this study were to examine the effect of a family-centered intervention program (FCIP) on neurophysiological functions in preterm infants with very low birth weight (VLBW; birth weight of < 1500 g) in Taiwan, to compare the effect of the FCIP with that of a usual-care program (UCP), and to explore the FCIP-induced changes in neurobehavioral and neurophysiological functions. Design This was a multicenter, single-blind randomized controlled trial. Setting The study took place in 3 medical centers in northern and southern Taiwan. Participants Two hundred fifty-one preterm infants with VLBW were included. Intervention The FCIP group received a family-centered intervention and the UCP group received standard care during hospitalization. Measurements Infants were assessed in terms of neurobehavioral performance using the Neonatal Neurobehavioral Examination–Chinese version, and their neurophysiological function was assessed using electroencephalography/event-related potentials during sleep and during an auditory oddball task during the neonatal period. Results The FCIP promoted more mature neurophysiological function than the UCP, including greater negative mean amplitudes of mismatch negativities in the left frontal region in the oddball task in all infants, lower intrahemispheric prefrontal-central coherence during sleep in infants who were small for gestational age, and higher interhemispheric frontal coherence during sleep in those who were appropriate for gestational age. Furthermore, interhemispheric coherence was positively associated with the total neurobehavioral score in preterm infants who were appropriate for gestational age (r = 0.20). Limitations The fact that more parental adherence strategies were used in the FCIP group than in the UCP group might have favored the intervention effect in this study. Conclusions Family-centered intervention facilitates short-term neurophysiological maturation in preterm infants with VLBW in Taiwan.

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The neurological examination of non-complicated preterm newborns using the Saint-Anne Dargassies Scale from birth to term

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2010000600012 ◽

2010 ◽

Vol 68 (6) ◽

pp. 893-897 ◽

Cited By ~ 1

Author(s):

Carla Ismirna Santos Alves ◽

Áurea Nogueira de Melo

Keyword(s):

Preterm Infants ◽

Neurological Examination ◽

Head Circumference ◽

Perinatal Period ◽

Neurological Complications ◽

Premature Newborns ◽

Anova Test ◽

Significant Difference ◽

Preterm Newborns

OBJECTIVE: To describe the maturational development of 20 (aged 32-36 weeks) premature newborns (PNBs) without clinical or neurological complications from birth until term. METHOD: The Saint-Anne Dargassies Scale was applied every two weeks until the age of 37 weeks. RESULTS: The PNBs showed normal Apgar and the growth in head circumference was adequate for postmentrual age. The Friedman ANOVA test found a significant difference only for the heel-to-ear angles from birth until term. The Saint-Anne Dargassies Scale detected changes in 11 PNBs and the most altered reflexes were: cardinal points, Moro, cross extension reflexe and automatic walking. These changes were found in the first 48 hours of life and in subsequent weeks until term. CONCLUSION: This finding alone justifies the neurological examination of PNBs, even if they show no clinical/neurological complications in the perinatal period and the importance of neuromotor assessment in preterm infants, as it enables detection and appropriate intervention.

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Harmonic Scalpel Tonsillectomy: A Systematic Review of Evidence for Postoperative Hemorrhage

Otolaryngology ◽

10.1016/j.otohns.2007.05.003 ◽

2007 ◽

Vol 137 (3) ◽

pp. 378-384 ◽

Cited By ~ 14

Author(s):

Codruta Neumann ◽

Ian Street ◽

David Lowe ◽

Holger Sudhoff

Keyword(s):

Harmonic Scalpel ◽

Postoperative Hemorrhage ◽

Cochrane Library ◽

Controlled Trials ◽

Large Sample Size ◽

Hemorrhagic Complication ◽

Exclusion Criteria ◽

Randomized Controlled ◽

Significant Difference ◽

Language Of Publication

OBJECTIVE: To systematically review the literature on harmonic scalpel tonsillectomy with a view of comparing its postoperative hemorrhagic rate with the conventional methods for tonsillectomy. DATA SOURCES: Cochrane Library, Medline, Embase, CINAHL, INAHTA, CRD (Centre for Review and Dissemination, York, UK), and related databases. The date of the last search was September 19, 2006; papers were considered irrespective of language of publication. REVIEW METHODS: Inclusion and exclusion criteria were applied independently by two reviewers with a third reviewer available for adjudication. The papers were quality assessed using Chalmers' criteria. Eleven randomized controlled trials (RCT) were included in the final review with five RCTs comparing harmonic scalpel tonsillectomy with “cold steel” tonsillectomy and six RCTs comparing harmonic scalpel with “hot” tonsillectomy techniques. RESULTS: All studies were underpowered to detect a significant difference in the postoperative hemorrhagic complication between harmonic scalpel and the comparator tonsillectomy techniques. The heterogeneity of studies made quantitative combination of results impossible. CONCLUSION: The evidence reviewed is of low quality and does not support any significant difference in postoperative hemorrhage rates when harmonic scalpel is compared with other tonsillectomy techniques. As studies have numerous methodological flaws and incorporate biases and confounding factors, these results need to be interpreted with caution. Larger and better-conducted studies would be needed in order to compare the safety of harmonic against conventional tonsillectomy methods. The need for a large sample size might make an RCT impractical; therefore a large, well-controlled cohort study could be more suitable.

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A Meta-analysis on the Effect of Kangaroo Mother Care on Preterm Mortality

Acta Medica Philippina ◽

10.47895/amp.v55i9.3745 ◽

2021 ◽

Vol 55 (9) ◽

Author(s):

Maria Esterlita T. Villanueva-Uy ◽

Michael Q. Van Haute ◽

Erena S. Kasahara ◽

Socorro De Leon-Mendoza

Keyword(s):

Birth Weight ◽

Preterm Infants ◽

Gestational Age ◽

Kangaroo Mother Care ◽

Country Of Birth ◽

Middle Income ◽

Middle Income Countries ◽

Randomized Controlled ◽

Subgroup Analyses ◽

Length Of Hospitalization

Background. Kangaroo mother care (KMC) is a low-cost but high-impact intervention for preterm and low birth weight (LBW) infants. Objectives. To determine the effect of KMC on in-hospital mortality among preterm and LBW infants, taking into consideration their gestational age, birth weight, income category of the country of birth, and medical stability. Materials and Methods. A comprehensive search of several databases, as well as local listings of research papers, was performed to look for randomized controlled studies with KMC as intervention, and mortality and length of hospitalization as outcome measures. The risk of bias and publication bias was assessed. We did subgroup analyses based on income category of the country of birth, gestational age, birth weight, and medical stability of the infants. Results. Sixteen randomized controlled trials (RCTs) with 1738 infants in the KMC group and 1674 infants in the control group were included. Based on the GRADE approach, although all the studies were RCTs, the evidence is assessed as moderate certainty due to the nature of the intervention (KMC) that prevented blinding. There was a 41% reduction in risk of dying among preterm and low birth weight infants who received KMC compared to conventional medical care (3.86%% vs 6.87%; RR = 0.59, 95% CI 0.44, 0.79; I2 = 0%; number needed to treat for additional benefit (NNTB) = 34; 16 RCTs; 3,412 infants). Furthermore, there were also reductions in the risk of dying among infants who were <34 weeks AOG (KMC: 4.32% vs CMC: 8.17%, RR = 0.55, 95% CI 0.38, 0.79; I2 = 0%; NNTB = 26; 10 RCTs; 1795 infants), with birthweight of >1500 g (KMC: 3.97% vs CMC: 6.83%, RR = 0.60; 95% CI 0.45, 0.82; I2 = 0%; NNTB = 35; 10 RCTs; 2960 infants), and born in low- and middle income countries (LMIC) (3.77% vs 6.95%; RR = 0.57, 95% CI 0.43, 0.77; I2 = 0%; NNTB = 32; 14 RCTs; 3281 infants). There was a significant reduction in mortality (KMC: 11.05% vs CMC: 20.94%; RR = 0.54; 95% CI 0.34, 0.87; I2 = 0%; NNTB = 11; 5 RCTs; 387 infants) even among medically unstable infants who received KMC compared to those who did not. The length of hospitalization did not significantly differ between the KMC and the control groups. Due to high heterogeneity, subgroup analyses were performed, which showed a trend towards a shorter length of hospital stay among preterm infants <34 weeks AOG, with birthweight ≥1500 g, medically unstable during admission, and belonging to LMIC but did not reach statistical significance. Conclusion. There was moderate certainty evidence that KMC can decrease mortality among preterm and LBW infants. Furthermore, KMC was beneficial among relatively more premature, bigger, medically unstable preterm infants and born in low to middle-income countries.

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Synbiotics use for preventing sepsis and necrotizing enterocolitis in very low birth weight neonates: a randomized controlled trial

Clinical and Experimental Pediatrics ◽

10.3345/cep.2019.00381 ◽

2020 ◽

Vol 63 (6) ◽

pp. 226-231 ◽

Cited By ~ 1

Author(s):

Ozge Serce Pehlevan ◽

Derya Benzer ◽

Tugba Gursoy ◽

Guner Karatekin ◽

Fahri Ovali

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Low Birth Weight ◽

Necrotizing Enterocolitis ◽

Gestational Age ◽

Very Low Birth Weight ◽

Late Onset ◽

Controlled Trial ◽

Randomized Controlled ◽

Significant Difference

Background: Probiotics and prebiotics have strain-specific effects on the host. Synbiotics, a mixture of probiotics and prebiotics, are proposed to have more beneficial effects on the host than either agent has alone.Purpose: We performed a randomized controlled trial to investigate the effect of Lactobacillus and Bifidobacterium together with oligosaccharides and lactoferrin on the development of necrotizing enterocolitis (NEC) or sepsis in very low birth weight neonates.Methods: Neonates with a gestational age ≤32 weeks and birth weight ≤1,500 g were enrolled. The study group received a combination of synbiotics and lactoferrin, whereas the control group received 1 mL of distilled water as placebo starting with the first feed until discharge. The outcome measures were the incidence of NEC stage ≥2 or late-onset cultureproven sepsis and NEC stage ≥2 or death.Results: Mean birth weight and gestational age of the study (n=104) and the control (n=104) groups were 1,197±235 g vs. 1,151±269 g and 29±1.9 vs. 28±2.2 weeks, respectively (P>0.05). Neither the incidence of NEC stage ≥2 or death, nor the incidence of NEC stage ≥2 or late-onset culture-proven sepsis differed between the study and control groups (5.8% vs. 5.9%, P=1; 26% vs. 21.2%, P=0.51). The only significant difference was the incidence of all stages of NEC (1.9% vs. 10.6%, P=0.019).Conclusion: The combination of synbiotics and lactoferrin did not reduce NEC severity, sepsis, or mortality.

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Effects of Late Surfactant Treatment Delivered After a Recruitment Maneuver on Respiratory Outcomes in Extremely Low Gestational Age Newborns: A Randomized Controlled Pilot Trial – LATE-REC-SURF Trial.

10.21203/rs.3.rs-1181889/v1 ◽

2022 ◽

Author(s):

Alessandra Lio ◽

Chiara Tirone ◽

Milena Tana ◽

Claudia Aurilia ◽

Rita Blandino ◽

...

Keyword(s):

Mechanical Ventilation ◽

Lung Injury ◽

Preterm Infants ◽

Gestational Age ◽

Pilot Trial ◽

Recruitment Manoeuvre ◽

Pulmonary Insufficiency ◽

Invasive Ventilation ◽

Preterm Babies ◽

Preterm Newborns

Abstract Background Mechanical ventilation is still needed in most preterm newborns, even in the non-invasive ventilation era. Ventilator-induced lung injury is one of the known pathogenetic factors of bronchopulmonary dysplasia (BPD) in preterm newborns. Lung injury has several patterns including surfactant dysfunction. Some recent trials have showed that a late surfactant administration can improve respiratory outcome in preterm babies still on invasive ventilation after the first week of life. Unfortunately, these results are still not conclusive. Moreover, giving surfactant after a recruitment manoeuvre in High Frequency Oscillatory Ventilation (HFOV) was shown to be safe and to reduce mortality in extremely preterm infants in a recent RCT. Our aim is to test the hypothesis that endotracheal administration of poractant-alfa preceded by a recruitment manoeuvre in HFOV in preterm infants still requiring mechanical ventilation at 7-10 days of life could facilitate extubation. Methods/Design: This will be an unblinded monocentric pilot trial that will be conducted in a III level Neonatal Intensive Care Unit at Fondazione Policlinico Agostino Gemelli IRCCS in Rome - Italy. Preterm newborns with a gestational age < 28 weeks still requiring invasive mechanical ventilation at 7-10 days of life with a fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours will be eligible for the study. Patients will be randomly assigned to intervention or to standard care. Intervention group infants will receive up to 4 doses of Poractant-alfa every 12 hours, each dose preceded by a recruitment manoeuvre in HFOV, until extubation. Primary endpoint will be the first successful extubation. Discussion Surfactant therapy is nowadays recommended in case of RDS in the first days of life but little is known about its effects in ventilator-dependant preterm newborns. Late administration of surfactant could help healing the lung of preterm babies in which RDS is evolving in a chronic pulmonary insufficiency of prematurity. The findings of this pilot trial will permit evaluation of the study design for a full-scale RCT. Trial registration: Clinicaltrials.gov – ID NCT04825197. Registered 12 April 2021, https://clinicaltrials.gov/ct2/home

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Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants

QJM ◽

10.1093/qjmed/hcaa063.002 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

H A Awad ◽

M M Elganzoury ◽

S S Emam ◽

G I Gad ◽

R A H Elfarrash ◽

...

Keyword(s):

Physical Activity ◽

Range Of Motion ◽

Preterm Infants ◽

Musculoskeletal System ◽

Gestational Age ◽

Exercise Group ◽

Magnesium Concentration ◽

Significant Difference ◽

Physical Activity Programs ◽

And Control

Abstract Background osteopenia of prematurity, also known as bone metabolic disorder, is one of the common diseases in very low birth weight (VLBW) prematurity. Aim of the Work the primary aim of this study was to assess whether physical activity programs in preterm infants improve bone mineralization as well as growth and reduce the risk of fractures. The secondary aim was to include other potential benefits in terms of length of hospital stay, weaning from mechanical ventilation, feeding tolerance and adverse events. Patients and Methods this study was conducted on 36 neonate, Preterm infants (gestational age <33 completed weeks), body size appropriate for gestational age according to the growth curve, Postnatal age of ≥ 1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity, tolerating enteral feeds of preterm formula at or above 100 kcal/kg/d. Methods the studied neonates were randomized into the physical exercise (n = 18) and control (n = 18) groups. Randomization was made by birth order. The studied neonates were subjected to full history taking, complete clinical assessment together with complete blood picture, C-reactive protein, serum Ca, Serum phosphorous concentration, Serum magnesium concentration. Serum alkaline phosphatase concentration, Serum Alanine Aminotransferase (ALT), Urinary calcium/phosphorous ratio. Babies admitted to NICU bathed, placed in incubator, attached to monitor. Infants in treatment and control groups received well defined interventions for the exercise group, systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital. Results the study demonstrated non significant difference in weight at enrollment (p = 0.516) which was turned into significant difference at end of the study as being higher among exercise group (p < 0.001). In our study although there was increase in the length and head circumference (p < 0.001) in the 2 groups no significant difference detected comparing them together. The control group had significantly lower serum phosphorus (p < 0.001), higher urinary Ca/Po4 ratio (p < 0.035) and higher ALP (p < 0.005) compared to excerise group at the end of the exercising protocol. Conclusion our study has demonstrated that regular physical activity programs (range-of-motion exercises), after an initial period of stabilization, might provide a simple intervention for improving musculoskeletal system and skeletal growth in preterm infants. They may also promote general growth in preterm infants.

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