Non-invasive Intervention for Apnea of Prematurity
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Women's Studies, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | February 2016 |
Neuromodulation of Limb Proprioceptive Afferents Using a Vibratory Device to Decrease Apnea, Intermittent Hypoxia and Bradycardia of Prematurity.
Purpose of Study: Apnea of Prematurity (AOP) is common, affecting the majority of infants
born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH),
which contributes to multiple pathologies, including retinopathy of prematurity (ROP),
sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and
neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning,
positive pressure ventilation, and caffeine therapy, none of which is optimal. The objective
is to support breathing in premature infants by using a simple, non-invasive vibratory
device placed over limb proprioceptor fibers, an intervention using the principle that limb
movements facilitate breathing.
Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were
enrolled 1 week after birth. Caffeine therapy was not a reason for exclusion. Small
vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF
sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2),
and breathing pauses were continuously collected.
born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH),
which contributes to multiple pathologies, including retinopathy of prematurity (ROP),
sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and
neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning,
positive pressure ventilation, and caffeine therapy, none of which is optimal. The objective
is to support breathing in premature infants by using a simple, non-invasive vibratory
device placed over limb proprioceptor fibers, an intervention using the principle that limb
movements facilitate breathing.
Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were
enrolled 1 week after birth. Caffeine therapy was not a reason for exclusion. Small
vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF
sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2),
and breathing pauses were continuously collected.
Aim: To study the effect of limb proprioceptive stimulation using a vibratory device on
apneic events, intermittent hypoxic episodes and bradycardias in a premature infant with
apnea of prematurity.
The objective is to provide support and to assist impaired ventilation and oxygenation in
apnea of prematurity (AOP). Recurrent apnea and accompanying resultant intermittent hypoxic
(IH) episodes are significant concerns commonly encountered in premature infants, and
optimal management is a challenge to neonatologists. AOP is defined as "a pause of breathing
for more than 15-20 seconds or accompanied by oxygen desaturation (SpO2<80% for>4s) and
bradycardia (heart rate<2/3 of baseline for>4s), in infants born less than 37 weeks of
gestation [Moriette G et al., 2010]. When these pauses are longer (> 15s), they are
frequently prolonged by obstructed inspiratory efforts, most likely secondary to loss of
upper airway tonic activity [Martin RJ et al., 2012]. In extremely low birth weight (ELBW)
infants, the incidence of IH progressively increases over the first 4 weeks of postnatal
life, followed by a plateau and subsequent decline between 6-8 weeks.
The incidence of AOP correlates inversely with gestational age and birth weight. Nearly all
infants born <29 weeks gestation or <1,000 g [Robertson CM et al., 2009], 54% at 30 to 31
weeks, 15% at 32 to 33 weeks, and 7% at 34 to 35 weeks gestation exhibit AOP [Martin RJ et
al]. Both animal and human evidence show that immature or impaired respiratory control and
the resultant IH exposure contribute to a variety of pathophysiologic issues via
pro-inflammatory and/or pro-oxidant cascade as well as cellular mechanisms, e.g., apoptosis,
leading to acute and chronic morbidities (e.g. retinopathy of prematurity, altered growth
and cardiovascular regulation, disrupting zinc homeostasis which hampers insulin production
and there by predisposing to diabetes in later life, cerebellar injuries and
neurodevelopmental disabilities) [Martin RJ et al., 2004, Pae EK et al., 2011, 2014, ].
Current standard of care for AOP includes prone positioning, continuous positive airway
pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV) to prevent
pharyngeal collapse and alveolar atelectasis, and methylxanthine therapy (caffeine,
theophylline), which is the mainstay of treatment of central apnea [Reher et al., 2008;
Pantalitschka T et al., 2009; Moretti C et al., 2012; Henderson-Smart DJ et al., 2010].
Apart from prone positioning, none of these interventions are optimal for early development.
CPAP masks will distort the bony facial structure in early development, and methylxanthine
interventions pose serious questions of neural development interactions.
Hypothesis: Applying slight vibration to the limbs will reduce the number of breathing
pauses, intermittent hypoxic episodes and bradycardias in apnea of prematurity.
apneic events, intermittent hypoxic episodes and bradycardias in a premature infant with
apnea of prematurity.
The objective is to provide support and to assist impaired ventilation and oxygenation in
apnea of prematurity (AOP). Recurrent apnea and accompanying resultant intermittent hypoxic
(IH) episodes are significant concerns commonly encountered in premature infants, and
optimal management is a challenge to neonatologists. AOP is defined as "a pause of breathing
for more than 15-20 seconds or accompanied by oxygen desaturation (SpO2<80% for>4s) and
bradycardia (heart rate<2/3 of baseline for>4s), in infants born less than 37 weeks of
gestation [Moriette G et al., 2010]. When these pauses are longer (> 15s), they are
frequently prolonged by obstructed inspiratory efforts, most likely secondary to loss of
upper airway tonic activity [Martin RJ et al., 2012]. In extremely low birth weight (ELBW)
infants, the incidence of IH progressively increases over the first 4 weeks of postnatal
life, followed by a plateau and subsequent decline between 6-8 weeks.
The incidence of AOP correlates inversely with gestational age and birth weight. Nearly all
infants born <29 weeks gestation or <1,000 g [Robertson CM et al., 2009], 54% at 30 to 31
weeks, 15% at 32 to 33 weeks, and 7% at 34 to 35 weeks gestation exhibit AOP [Martin RJ et
al]. Both animal and human evidence show that immature or impaired respiratory control and
the resultant IH exposure contribute to a variety of pathophysiologic issues via
pro-inflammatory and/or pro-oxidant cascade as well as cellular mechanisms, e.g., apoptosis,
leading to acute and chronic morbidities (e.g. retinopathy of prematurity, altered growth
and cardiovascular regulation, disrupting zinc homeostasis which hampers insulin production
and there by predisposing to diabetes in later life, cerebellar injuries and
neurodevelopmental disabilities) [Martin RJ et al., 2004, Pae EK et al., 2011, 2014, ].
Current standard of care for AOP includes prone positioning, continuous positive airway
pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV) to prevent
pharyngeal collapse and alveolar atelectasis, and methylxanthine therapy (caffeine,
theophylline), which is the mainstay of treatment of central apnea [Reher et al., 2008;
Pantalitschka T et al., 2009; Moretti C et al., 2012; Henderson-Smart DJ et al., 2010].
Apart from prone positioning, none of these interventions are optimal for early development.
CPAP masks will distort the bony facial structure in early development, and methylxanthine
interventions pose serious questions of neural development interactions.
Hypothesis: Applying slight vibration to the limbs will reduce the number of breathing
pauses, intermittent hypoxic episodes and bradycardias in apnea of prematurity.
Inclusion Criteria:
1. Gestational age > 23 weeks, < 34 weeks
2. At least 1 week old at recruitment
3. Diagnosis of apnea of prematurity (AOP)
4. Caffeine treatment will not be an exclusion
Exclusion Criteria:
1. Infants with major congenital anomalies/malformations which will influence central
nervous system and long-term outcomes in these infants, such as cardiac anomalies
(except for Patent Ductus Arteriosus or Ventricular Septal Defect) or major
neurological malformations, like meningoencephalocele, holoprosencephaly etc.
2. Neonates who have apnea from airway issues like laryngomalacia or tracheomalacia
3. Neonates with history of hypoxic ischemic encephalopathy or Grade IV intraventricular
hemorrhage
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