Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol

2020 ◽  
Vol 57 (2) ◽  
pp. 219-242 ◽  
Author(s):  
Dana Yakobson ◽  
Shmuel Arnon ◽  
Christian Gold ◽  
Cochavit Elefant ◽  
Ita Litmanovitz ◽  
...  
Keyword(s):  
Music Therapy ◽  
Preterm Infants ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Infant Attachment ◽  
Developmental Care ◽  
Sensory Regulation ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Attachment Quality

Abstract Music therapy (MT) interventions and skin-to-skin care (SSC) both aim to address the varied needs of preterm infants, including sensory regulation and stress reduction, inclusion of parents in their infant’s care, support of parents’ emotional state, and enhancing the parent–infant attachment process. Few studies have investigated the combination of both modalities through randomized controlled trials. Evidence of longer-term effects is missing. This article presents a study protocol that will investigate the effects of combined family-centered MT intervention and SSC on preterm-infants’ autonomic nervous system (ANS) stability, parental anxiety levels, and parent–infant attachment quality. 12 clusters with a total of 72 preterm infants, with their parents, will be randomized to one of two conditions: MT combined with SSC or SSC alone. Each parent–infant dyad will participate in 3 sessions (2 in the hospital and a 3-month follow-up). The primary outcome of preterm infants’ ANS stability will be measured by the high frequency power of their heart rate variability. Secondary outcomes will be physiological measures and behavioral states in infants and anxiety and attachment levels of parents. This trial will provide important, evidence-based knowledge on the use of the “First Sounds: Rhythm, Breath, and Lullaby” model of MT in neonatal care, through an intervention that is in line with the Newborn Individualized Developmental Care and Assessment Program model for supportive developmental care of preterm infants and their parents. Ethical approval (no. 0283-15) was granted from the local Institutional Review Board in April 2017. This trial is registered in ClinicalTrials.gov, NCT03023267.

The impact of music therapy on pain and stress reduction during oocyte retrieval – a randomized controlled trial

2018 ◽  
Vol 37 (2) ◽  
pp. 145-152 ◽  
Author(s):  
Cosy Wing Ching Cheung ◽  
Alice Wong Wai Yee ◽  
Pui Shan Chan ◽  
Sotirios H. Saravelos ◽  
Jacqueline Pui Wah Chung ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Music Therapy ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Oocyte Retrieval ◽  
Randomized Controlled ◽  
The Impact

scholarly journals Patent ductus arteriosus, systemic NT-proBNP concentrations and development of bronchopulmonary dysplasia in very preterm infants: retrospective data analysis from a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Solomiia Potsiurko ◽  
Dmytro Dobryanskyy ◽  
Lesya Sekretar
Keyword(s):  
Randomized Controlled Trial ◽  
Patent Ductus Arteriosus ◽  
Preterm Infants ◽  
Roc Curve ◽  
Controlled Trial ◽  
Ductus Arteriosus ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Patent Ductus

Abstract Background Patent ductus arteriosus (PDA) is a common complication in very preterm infants. It is known that there is an association between PDA and development of bronchopulmonary dysplasia (BPD) or death before the postmenstrual age (PMA) of 36 weeks, but this association remains one of the most controversial aspects of the problem. The study aimed to evaluate the relationship between PDA, serum NT-proBNP levels at 2–3 and 8–9 days of life, and BPD/death in very preterm infants. Methods Data of 52 preterm infants with a gestational age < 32 weeks, chronological age < 72 h, and PDA diameter > 1.5 mm, enrolled in a randomized controlled trial, were used for the retrospective analysis. All patients underwent daily echocardiographic and two serum NT-proBNP measurements within the first 10 days after birth. Two groups of infants were formed retrospectively at PMA of 36 weeks depending on the outcome, BPD (n = 18)/death (n = 7) or survival without BPD (n = 27). Receiver operator characteristic (ROC) curve was used to evaluate the predictive performance of serum NT-proBNP levels for BPD/death occurrence. Results The percentage of infants who received pharmacological treatment for PDA did not differ between the groups. Based on the area under the ROC curve, serum NT-proBNP levels on the 2–3 day of life (AUC = 0.71; 95% confidence interval (CI): 0.56–0.9; p = 0.014)) and on the 8–9 day of life (AUC = 0.76; 95% CI: 0.6–0.9; p = 0.002) could reliably predict BPD/death in very preterm infants who had PDA diameter > 1.5 mm in the first 72 h of life. Hemodynamically significant PDA (hsPDA) was significantly more often detected in newborns with BPD/death, however, treatment of infants with hsPDA did not reduce the incidence of BPD/death. Conclusions In very preterm infants with PDA > 1.5 mm at the age of 24–48 h, serum NT-proBNP concentration could reliably predict the development of BPD or death, regardless of the persistence of PDA, with the highest diagnostic value at 8–9 days. Trial registration This study is registered in ClinicalTrials.gov - NCT03860428 on March 4, 2019.

scholarly journals Non-invasive high-frequency oscillatory ventilation in preterm infants after extubation: a randomized, controlled trial

2021 ◽  
Vol 49 (2) ◽  
pp. 030006052098491
Author(s):  
Yan Li ◽  
Qiufen Wei ◽  
Dan Zhao ◽  
Yan Mo ◽  
Liping Yao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Infants ◽  
High Frequency ◽  
Controlled Trial ◽  
High Frequency Oscillatory Ventilation ◽  
Positive Pressure ◽  
Non Invasive ◽  
Randomized Controlled ◽  
Oscillatory Ventilation ◽  
High Frequency Oscillatory

Objective To investigate the effectiveness and safety of non-invasive high-frequency oscillatory ventilation (NHFOV) in post-extubation preterm infants. Methods This was a randomized, controlled trial. A total of 149 preterm infants aged between 25 to 34 weeks’ gestational age with a birth weight of <1500 g who required invasive mechanical ventilation on admission were included. After extubation, they were randomized to the NHFOV group (n = 47), nasal intermittent positive pressure ventilation (NIPPV) group (n = 51), or nasal continuous positive airway pressure (NCPAP) group (n = 51). We compared the effectiveness and safety among these three groups. Results A total of 139 preterm infants finally completed the study. The reintubation rate was significantly lower in the NHFOV group than in the other groups. The duration of non-invasive ventilation and the length of hospital stay in the NHFOV and NIPPV groups were significantly shorter than those in the NCPAP group. The incidence of bronchopulmonary dysplasia in the NHFOV and NIPPV groups was significantly lower than that in the NCPAP group. The NHFOV group had significantly less nasal injury than the NCPAP group. Conclusion As post-extubation respiratory support in preterm infants, NHFOV has a lower reintubation rate compared with NCPAP and NIPPV, without increasing the rate of complications.

The Effect of Individualized Developmental Care Practices in Preterm Infants

2019 ◽  
Vol 27 (2) ◽  
pp. 97-104
Author(s):  
Dilek Küçük Alemdar ◽  
Sevil İnal
Keyword(s):  
Breast Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Oral Feeding ◽  
Control Group ◽  
Developmental Care ◽  
Significant Difference ◽  
Care Practices ◽  
Maternal Voice

Background: Preterm infants are vulnerable humans requiring much care and attention. They may be exposed to irregular noise, light, and odor in the neonatal intensive care unit for a period of several weeks or months. This study was carried out to determine the effect of individualized developmental care on physiological parameters, growth, and transition to oral feeding in preterm infants. Methods: The study was a randomized controlled trial. The sample comprised premature infants meeting the inclusion criteria. They were randomly assigned to four groups: the maternal voice group, the breast milk odor (BMO) group, the incubator cover (IC) group, and the control group. Results: No statistically significant difference was found between the groups in terms of weight, height, and head circumference at time of discharge. Mean SO2 values were statistically higher in the IC group than the other groups; however, the heart rate and respiratory rate were not statistically different in a significant sense between the groups. The briefest duration of transition to total oral feeding was seen in the BMO group. Conclusion: Individualized developmental care practices based on the results of these interventions are likely to support the care of preterm infants. Breast milk odor may ease the transition to breastfeeding.

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