Publication: RCT: Neuroprotective Core Measure 2: Partnering with Families - Effects of a Weighted Maternally-Scented Parental Simulation Device [The Zaky HUG] on Premature Infants in Neonatal Intensive Care

Randomized Control Trial at the Regional Medical Center of Central Georgia, in Macon, Georgia, USA, and funded by Georgia College.

Presented at the American Public Health Association's (APHA) Annual Conference 2011,
National Association of Neonatal Nurses (NANN) Annual Conference 2012

Conclusion:

Neuroprotective supportive care using a weighted maternally-scented parental simulation device [The Zaky HUG] 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
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

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.

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.

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.

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.