Prone Positioner Device for Infant Development

Overseen By Jennifer A Marshall, MPH, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Age > 24 months, Medically unstable, Recent surgery, Weightbearing restrictions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Prone Positioner for infants with tracheostomies (trachs), which are tubes in the neck that assist with breathing. The researchers aim to evaluate the device's fit and gather satisfaction feedback from families and healthcare providers. They also seek to determine if the device aids babies with trachs in participating in tummy time, a crucial developmental activity. The trial seeks infants in the hospital or clinic with trachs who can be safely monitored during the study. Families and healthcare providers will provide feedback on the device to help refine its design and use. As an unphased trial, this study allows families to contribute to developing a potentially beneficial device for infants with trachs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for infants with tracheostomies?

Research has shown that using a prone positioner device for babies, especially in neonatal intensive care units, is generally safe. One study found that placing premature babies in a prone positioner did not affect their heart and breathing rates, indicating that babies tolerate the device well. Another study supports that these devices help babies find a comfortable position, which is important for growth. These findings suggest that the prone positioner is a safe choice for babies, particularly those with special needs like tracheostomies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prone Positioner for infant development because it offers a novel approach to enhancing motor skills and reducing the risk of developmental delays. Unlike traditional methods that rely on standard tummy time practices, this device provides a structured and consistent way to expose infants to the prone position, potentially leading to more effective outcomes. By ensuring a safe and supportive environment for infants to explore this position, the Prone Positioner might foster better physical and cognitive development compared to current practices.

What evidence suggests that the Prone Positioner is effective for infant development?

This trial will evaluate the Prone Positioner device for its effects on infant development. Studies have shown that using a device to position preterm infants on their stomachs can reduce stress behaviors. Research indicates that when infants lie on their stomachs, they experience less stress and show better muscle activity, particularly in core muscles like the abdominals. Some studies suggest that this position might also enhance oxygenation in certain children. However, other research found that lying on the stomach did not significantly improve outcomes such as the number of days children with lung injuries could breathe without a ventilator. Overall, the Prone Positioner appears to offer some benefits for comfort and muscle activity in infants. ^{3 4 6 7 8}

Who Is on the Research Team?

Brandi Dorton, DPT, NTMTC

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for inpatient infants with tracheostomies, aged >44 weeks gestational to 18 months, in the PICU or NICU. It includes various sizes/weights and any race/ethnicity. English-speaking caregivers and CM therapists unfamiliar with the device can participate. Excluded are infants over 18 months, medically unstable, recent surgery with complications, or upper extremity fractures.

Inclusion Criteria

I am either male or female.

Caregivers

My infant with a tracheostomy is in the PICU or NICU, aged over 44 weeks gestational to 18 months.

Exclusion Criteria

My infant had recent heart or belly surgery with complications.

Non-English speakers

My infant cannot put weight on their arms due to fractures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Fit Test

Participants are placed in the Prone Positioner, and their fit, comfort, and ventilation are monitored. Measurements are taken, and the ease of use is assessed.

45 minutes

1 visit (in-person)

Feedback Collection

Parents and healthcare providers are surveyed for their perceptions and feedback on the Prone Positioner.

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any delayed reactions or feedback after the initial use of the Prone Positioner.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prone Positioner

Trial Overview The study tests the Prone Positioner's fit and satisfaction for infants with trachs during tummy time. It evaluates if it allows proper ventilation while used and gathers aesthetic feedback from families and healthcare providers through surveys.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

Subjects who are placed in the Prone Positioner for evaluation

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

In a study of 74 infants with left congenital diaphragmatic hernia (CDH) without liver herniation, those with stomach-down CDH experienced significantly lower neonatal morbidity compared to those with stomach-up CDH, despite similar lung development indicators.

Stomach-down CDH patients had shorter durations of intubation and extracorporeal membrane oxygenation, and a lower rate of pulmonary hypertension, highlighting the importance of accurate prenatal ultrasound characterization for better management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased neonatal morbidity in 'stomach-down' left congenital diaphragmatic hernia: implications of prenatal ultrasound diagnosis for counseling and postnatal management. Didier, RA., Oliver, ER., Rungsiprakarn, P., et al.[2021]

The study involved 20 premature infants and assessed the effects of a specially designed prone positioner on their heart rate, respiratory rate, and scapular position.

While heart and respiratory rates remained unchanged, the prone positioner significantly improved scapular rotation, suggesting it may help prevent shoulder tightness in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a neonatal positioner on scapular rotation. Monfort, K., Case-Smith, J.[2019]

In a case study of 4 patients with ARDS, those who did not use preventive measures developed multiple necrotic facial pressure ulcers from prone positioning, highlighting the risk associated with this treatment.

Using thin silicone foam dressings during prone positioning effectively prevented facial pressure ulcers in patients, suggesting that this intervention can enhance patient safety during ARDS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Facial Pressure Ulcers in Acute Respiratory Distress Syndrome (ARDS). Kim, RS., Mullins, K.[2020]

In a study of 116 patients with congenital diaphragmatic hernia (CDH), those diagnosed prenatally (71 patients) had higher risk factors, such as liver herniation and the need for patch repair, compared to those diagnosed postnatally (45 patients).

Despite the higher risk in the prenatal group, both groups had the same 6-month survival rate of 73%, suggesting that prenatal evaluation and multidisciplinary management can effectively support high-risk CDH patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of prenatal evaluation and protocol-based perinatal management on congenital diaphragmatic hernia outcomes. Lazar, DA., Cass, DL., Rodriguez, MA., et al.[2018]

In a study of 13 neonates with congenital diaphragmatic hernia (CDH) who underwent repair with a modified anterior fundoplication, 10 patients survived to discharge, and 8 were able to achieve full oral nourishment, indicating the procedure's potential efficacy in improving post-operative feeding.

The modified fundoplication was safe, with no complications reported, and it effectively addressed anatomical issues that predispose these infants to severe gastroesophageal reflux (GER), suggesting it should be considered in the surgical management of high-risk infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior fundoplication at the time of congenital diaphragmatic hernia repair. Guner, YS., Elliott, S., Marr, CC., et al.[2021]

Implementing continuous incident reporting and prevention strategies led to a significant reduction in severe iatrogenic events in neonates, decreasing from 7.6 to 4.8 per 1000 patient-days over a two-year period.

Specific improvements included a notable drop in central catheter-related infections from 13.9 to 8.2 per 1000 catheter-days and a reduction in tenfold drug-dosing errors, although there was an increase in unplanned extubations from 5.6 to 15.5 per 1000 ventilation-days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic events in neonates: beneficial effects of prevention strategies and continuous monitoring. Ligi, I., Millet, V., Sartor, C., et al.[2022]

In a systematic review of 14,226 umbilical venous catheters (UVCs) and 4,228 umbilical arterial catheters (UACs), it was found that 13.4% of UVCs and 9% of UACs were associated with adverse events (AEs), indicating a significant risk in neonatal care.

The most common adverse event for UVCs was malposition (41.7%), highlighting the need for improved methods of catheter placement verification and monitoring to enhance safety in neonatal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with umbilical catheters: a systematic review and meta-analysis. Gibson, K., Sharp, R., Ullman, A., et al.[2023]

The study found that ICD-9-CM codes are highly effective in identifying adverse events in hospitalized patients, with a 100% accuracy for surgical and medical care misadventures.

For medication-related complications, the positive predictive value was 62.8%, and for complications from procedures, it was 56.8%, indicating that while the codes are useful, there is variability in their accuracy depending on the type of adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Positive predictive value of ICD-9-CM codes in hospital inpatient discharge abstract records, for identifying adverse events]. Gianino, MM., Borghese, R., Russo, R., et al.[2007]

The study analyzed 69 newborns with congenital diaphragmatic hernia (CDH) over 19 years, revealing a significant decrease in mortality from 22.2% in the earlier group (1995-2004) to 3.0% in the later group (2005-2014), attributed to improved prenatal diagnosis and perinatal care.

Prenatal diagnosis rates increased from 30.6% in the earlier group to 66.7% in the later group, and more newborns were delivered in tertiary perinatal hospitals (60% to 84.8%), indicating that better planning and care contributed to the improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outcome in congenital diaphragmatic hernia - experience of a tertiary center without ECMO. Pimenta, J., Vaz Silva, P., Pinto, C., et al.[2018]

This systematic review aims to evaluate the effectiveness of prolonged prone positioning (≥16 hours) compared to conventional management in patients with acute respiratory distress syndrome (ARDS), focusing on short-term mortality outcomes.

The study will also explore the optimal duration of prone positioning through meta-regression analysis, considering factors like patient severity and duration of mechanical ventilation, to better understand how these variables impact mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal duration of prone positioning in patients with acute respiratory distress syndrome: a protocol for a systematic review and meta-regression analysis. Kamo, T., Aoki, Y., Fukuda, T., et al.[2020]

In a study involving 30 premature infants, both prone and sitting positions showed little clinical difference in heart rates, respiration rates, and arterial oxygen saturation levels, indicating that sitting may be a safe alternative for these infants.

No episodes of apnea or bradycardia were observed during the study, suggesting that using a premature infant seat is a safe option for clinically stable premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of prone and sitting on heart rates, respiration rates, and arterial oxygen saturation levels of premature infants. Stap, LJ., Overbach, A., Reinhart, AP., et al.[2019]

In a study of 464 neonates with left-sided isolated congenital diaphragmatic hernia (CDH), the position of the nasogastric (NG) tube immediately after birth was found to be a significant prognostic factor, with a higher 90-day survival rate of 98.4% for those with the NG tube positioned below the diaphragm compared to 89.4% for those with it above the diaphragm.

The BD group not only had a higher survival rate but also experienced shorter durations of mechanical ventilation (11 days vs. 19 days) and hospitalization (38 days vs. 59 days), indicating that NG tube position is an important factor to consider in the management of CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of the postnatal nasogastric tube position as a prognostic marker of left-sided isolated congenital diaphragmatic hernia. Kono, J., Nagata, K., Terui, K., et al.[2022]

Prone positioning significantly improves oxygenation in patients with adult respiratory distress syndrome (ARDS), with measurable benefits observed at various time points (early, intermediate, and late) across multiple studies involving over 800 patients.

In patients with higher illness severity, prone positioning may lead to a significant reduction in mortality, suggesting it could be particularly beneficial for the most critically ill ARDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prone positioning in patients with acute respiratory distress syndrome: a meta-analysis. Alsaghir, AH., Martin, CM.[2020]

In a study of 44 preterm infants receiving N-CPAP, placing them in a prone position significantly reduced their heart rate (HR) and respiratory rate (RR) compared to the supine position, suggesting improved cardio-respiratory stability.

While prone positioning can be beneficial for preterm infants with respiratory distress, it should be used cautiously due to the associated risk of sudden infant death syndrome (SIDS), emphasizing the need for careful supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison the effect of Sleep Positioning on Cardiorespiratory Rate in Noninvasive Ventilated Premature Infants. Ghorbani, F., Asadollahi, M., Valizadeh, S.[2022]

Citations

1. withpower.com withpower.com/trial/phase-infant-development-8-2023-a33e3

Prone Positioner Device for Infant Development The study involved 20 premature infants and assessed the effects of a specially designed prone positioner on their heart rate, respiratory rate, and scapular ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281729/

The effect of the use of positioning materials and hand-face ... Studies have shown that preterm infants placed in the nested prone position have less stress behavior [23–25]. To provide the most suitable ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0021929020301573

Positioning and baby devices impact infant spinal muscle ... During prone positioning, the 20° inclined surface resulted in significantly higher muscle activity of the trunk core muscles (abdominals), ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/201187

Effect of Prone Positioning on Clinical Outcomes in ... Context In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1237036/

Effect of Prone Positioning on Clinical Outcomes in ... Conclusions. Prone positioning does not significantly improve ventilator-free days or other clinical outcomes in pediatric patients with acute lung injury.

6. int-bio.com int-bio.com/developmental-care/infant-positioning-aids/prone-plus/

Prone Plus Infant Positioning Aid The Prone Plus infant positioning aid supports premature and full-term infants in achieving the ideal prone position for optimal ventral support.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/4153523

“I Am Afraid of Positioning my Baby in Prone”: Beliefs and ... Data suggest that infants aged between one and six months practicing prone positioning daily are more likely to achieve motor skills ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0884217522003264

Systematic Review of the Effects of Positioning on ... Results suggested that infants experienced 3.4% more quiet sleep and 4.7% more active sleep when positioned in a side-lying position rather than a supine or ...