Neonatology Medical Staff
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Research The Zaky

Apnea_Bradycardia Research ResultsNurtured by Design is the first company in its class and we are breaking ground in the area of evidence-based ergonomic devices for neonatal developmental care that is centered in the relationship parent-child.

As the global leader of neonatal ergonomics we provide solutions that significantly improve the environment/habitat of newborns in thousands of homes and hundreds of hospitals globally. Our products have been independently and clinically evaluated and positively recommended by families and important personalities and institutions in the healthcare industry globally.

We remain loyal to our philosophy of researching the importance of the parents in the care of the babies and how to positive integrate them in each of our designs.

More than a portfolio of commercial products, we create devices inspired on human nature and maternal instinct that actually save lives and improve the quality of life of babies, families, and society at large - for a lifetime.

 

 

  • Poster and Video Presentation

  • Abstract

  •    Analysis

This research was published in the September, 2015 issue of the Newborn and Infant Nursing Reviews.

The Zaky® is a product by Nurtured by Design and it is the ergonomic device designed to provide nurturing developmental care to babies in the NICU since it was released in 2004 after 3 years of development.

It is now used in any unit in the hospital with babies and toddlers (pediatric/oncology/post partum/cardiology/etc.) and with healthy babies and children including those with working or traveling parents.

now it was proven to aid the premature infant’s in the study by significantly improving self-regulation and significantly decreasing apnea/bradycardia (Zero episodes for babies using maternally scented The Zaky).

It is our distinct honor to announce that the results of the independent randomized control trial about The Zaky have been published in the 2015 September issue of Newborn and Infant Nursing Reviews – click here for the publication.

This independent clinical research about the Zaky [maternal simulated intervention] was presented at the American Public Health Association's (APHA) Annual Meeting (Washington DC, Nov. 2011), and at the National Association of Neonatal Nurses (NANN) Annual Conference (Palm Springs, CA, Oct. 2012)

Neuroprotective Core Measure 2: Partnering with Families – Effects of a Weighted Maternally-Scented Parental Simulation Device on Premature Infants in Neonatal Intensive Care

It was funded in its entirety by Georgia College and performed at the Regional Medical Center of Central Georgia. We want to congratulate and thank the principal investigators and all the team that worked on this groundbreaking research:

  • Kendra Russell, PhD, RN – Macon Graduate Center, Georgia College & State University
  • Barbara Weaver, RN
  • Robert L. Vogel, Ph.D, – HSU College of Public Health, Georgia Southern University
Conclusion: Neuroprotective supportive care using a weighted maternally-scented parental simulation device resulted in increased physiologic stability of premature and early term infants through the promotion of self-regulation seen by reduction of stressful behaviors, and decreased apnea, and bradycardia.

VIDEO: Poster Research Presentation at the APHA Meeting, 2011
Washington DC: "Give them a hand to develop their brain"
By Barbara Weaver, RN,
NICU, Medical Center of Central Georgia,
Macon, GA

VIDEO: Conversation with Dr. Robert Vogel, PhD, principal investigator and biostatistician.
Professor of Biostatistics,
Jiann-Ping Hsu College of public Health,
Georgia Southern University,
Statesboro, GA
PosterPDF
Click here for the poster's PDF file

Abstract


 The Effect of a Maternal Simulated Intervention on Physiologic and Developmental Behaviors of 24-38 Week Gestation Infants in a Level III Neonatal Intensive Care Unit.

Kendra Russell, Ph.D., RN1, Barbara Weaver, RN2, Robert L. Vogel, Ph.D.3
1. SON - Georgia College, Milledgeville, GA 31061, 478-445-7135, kendra.russell1@gmail.com.
2. NICU, Medical Center of Central Georgia, Macon, GA 31210, 478-633-7389, cweaver@pstel.net
3. Jiann-Ping Hsu College of Public Health, Georgia, PO Box 8015 Southern University, Statesboro, GA, 30460, 912-478-7423, rvogel@georgiasouthern.edu

Problem: Complications of preterm delivery are associated with numerous developmental abnormalities that may impact the overall quality of life of the infant. The literature supports the use of many developmental interventions for premature infants convalescing in the Neonatal Intensive Care Unit (NICU). Interventions have been shown to be beneficial to premature infants by helping to increase weight gain, shortened hospital stay, and improve bonding (Dodd, 2005). A number of devices that support developmental positioning of premature infants are currently in use in many NICU’s. However, few of these support devices have been explored to determine the benefits for the infant. The purpose of this study was to explore a maternal simulated intervention on physiologic and developmental behaviors of 28-34 week gestation infants in a Level III NICU.

Method: Using a quasi-experimental design, a sample of 45 infants was randomized into four groups to explore differences over time when developmentally appropriate interventions were applied. Differences in pain scores, episodes of apnea/bradycardia, vital signs, and occurrences of self-regulatory and stress behaviors were observed.

Results: Infants receiving the maternal simulated intervention had fewer episodes of apnea/bradycardia (p <0.05). The odds of observing stress behaviors over time were higher for the standard of care than the odds for the simulated intervention (OR = 10.5, p<0.05).

Conclusion: Neuroprotective supportive care using a weighted maternally-scented parental simulation device [THE ZAKY] resulted in increased physiologic stability of premature and early term infants through the promotion of self-regulation seen by reduction of stressful behaviors, and decreased apnea, and bradycardia.

The Zaky Research - Analysis from the Poster and Presentation


All groups were provided with quiet environment with minimal stimulation, uninterrupted periods of sleep, individual infant beds shielded from light, dimming and cycling of overhead lighting, etc.

Group A = Standard nursing care providing positioning, containment, boundaries with various developmental care devices;
Group B = Using an unscented pair of The Zaky por positioning, boundaries, containment;
Group C = Using a maternally scented pair of The Zaky (mother scented the pair of The Zaky by placing it on the chest or behind the neck for one hour);
Group D = Standard nursing care (group A) and adding a maternally scented insert.

A. ) Descriptive Statistics: 
The following table describes the characteristics of the infants in each group.  It is clear there are no differences in age, apgars, or DOL, which suggests there are no biases due to those descriptive factors.

Variable

Group A mean(sd)
n=11

Group B mean(sd)
n=11

Group C mean(sd)
n=11

Group D mean(sd)
n=12

Age (weeks)

30.5 (4.6)

30.1 (3.7)

31.0 (3.9)

28.1 (4.0)

Apgar1

5.5 (2.7)

5.9 (2.4)

5.7 (1.9)

4.8 (2.4)

Apgar5

7.2 (2.3)

7.3 (2.0)

7.3 (1.6)

7.5 (1.3)

DOL

18.9 (23.9)

15.1 (19.7)

6.7 (6.4)

17.3(19.1)


B.) Logistic Regression Analysis on Self-Regulatory versus Stress Behaviors. 

In this analysis the concern is with respect to difference between groups and changes over time.  The variable(s) of interest are the seven self-regulatory variables measured over the six time periods.


Variable

O.R. group B versus group A
(95% Confidence Interval)

O.R. group C versus group A (95% C.I.)

O.R. group D versus group A
(95% C.I.)

SR1
Cardio-respiratory

0.095
(0.027, 0.337)

0.031
(0.004, 0.236)

0.482
(0.222, 1.293)

SR2
Color

0.803
(0.380, 1.701)

0.295
(0.120, 0.728)

0.662
(0.312,1.404)

SR3***
Feeding

Cannot calculate

Cannot calculate

2.026
(0.558, 7.362)

SR4
Body Movements

0.099
(0.044, 0.222)

0.060
(0.025, 0.141)

0.219
(0.102, 0.470)

SR5
Sleep / Wake

0.096
(0.042, 0.221)

0.110
(0.048, 0.252)

0.449
(0.197, 1.025)

SR6
Self Quieting

0.651
(0.327, 1.297)

0.301
(0.143, 0.632)

1.177
(0.602, 2.301)

SR7
Attentive Behaviors

0.565
(0.280, 1.142)

0.155
(0.072, 0.334)

0.474
(0.238, 0.947)

Notes: 

1.) The confidence intervals in bold indicate statistically significant odds ratios.  The outcome of interest is a score of “D.”  Thus, a statistically significant odds ratio less than 1 says that the odds of a disorganized response is less for the experimental treatment than the standard treatment.  If you invert the odds ratios,  you will get how much more likely the odds are of seeing a disorganized response for standard treatment.  For example, the OR for treatment B verses A for SR1 is 0.095.  It’s reciprocal (invert) is 10.5.  This means the odds of seeing a disorganized response for the standard care is 10.5 times more likely than for the unscented Zaky with a 95% confidence interval (3,37)
2.) The wide confidence intervals are a result of the sample size being modest.
3.) For SR3, there were very few disorganized responses over the four groups (12 of 270) as a result odds ratios could not be calculated for groups B and C.

In summary, there is evidence to suggest the unscented and scented Zaky are beneficial based on the above results for SR1, SR2, SR4, SR5, SR6, and SR7, with the maternally scented Zaky demonstrating a better response for all of the self regulatory items.  The scented insert used in Group D demonstrates modest benefit.

D.) Poisson Regression on Apnea and Bradycardia.


Group

Apnea Events

Bradycardia Events

Apnea_Bradycardia Research Results

A

40

45

B

22

26

C

0

0

D

44

49

Poisson regression results indicate the chances of seeing either apnea or a bradycardia event is about twice for standard nursing as opposed to the unscented Zaky.  As there were no events for the maternally scented Zaky, no estimate can be made.  However, no events indicate a considerable benefit and the table above says it all.


Poster Presentation of the research at the APHA Meeting, Nov 2, 2011
Washington DC:

"Give them a hand to develop their brain"

Barbara Weaver, RN ,
NICU, Medical Center of Central Georgia,
Macon, GA

Conversation with co-Principal Investigator Dr. Robert Vogel, PhD
Professor of Biostatistics,
Jiann-Ping Hsu College of public Health,
Georgia Southern University,
Statesboro, GA