Tactile stimulation to improve spontaneous breathing in neonatal resuscitation

Although ample research has improved our respiratory and hemodynamic care for
very preterm infants during the neonatal period, our care at birth has been a
neglected area until recent years (te Pas 2008, van Vonderen 2014). For
successful transition to life after birth some major respiratory and
hemodynamic physiological changes have to occur (van Vonderen 2014, Hooper
2005). In preterm infants the immature respiratory system often complicates
this transition at birth (Hooper 2005, Polglase 2012). Consequently, preterm
infants often need respiratory support immediately after birth. To minimise
injury, intubation and mechanical ventilation is now avoided and the focus of
respiratory care has shifted to non-invasive ventilation (positive pressure
support of breathing and/or ventilation via facemask)(van Vonderen 2012,
O*Donnell 2012). In human infants, tactile manoeuvres (warming, drying and
rubbing the back or the soles of the feet) to stimulate breathing have been
recommended during the initial assessment of the infant at birth (Lee 2011).
These interventions alone would help 10% of all infants that need assessment
after birth to achieve spontaneous breathing (expert*s opinion) (Wall 2009).
Because it is assumed that tactile stimulation during initial assessment
promotes breathing, it is currently recommended in the international
resuscitation guidelines (WHO 2012). Although this is commonly accepted
intervention, there are no human studies demonstrating the effect of
stimulation on breathing at birth, especially in preterm infants.

The objective of this study is to compare the direct effect of repetitive
tactile stimulation versus standard stimulation on the respiratory effort of
preterm infants during stabilisation at birth.
The most ideal comparison would be to compare stimulation vs no stimulation,
however most clinicians would not feel comfortable to abandon stimulation if
they think the infant would need it. However, reviewing the delivery room
recordings demonstrated that stimulation is frequently not performed.

Currently, multiple studies are conducted in our center to stimulate
spontaneous breathing after birth. This study is one of the interventions that
might be used for stimulating spontaneous breathing. The results of this study
will be used for generating hypothesis/rationale for a larger randomized study
with a primary clinical outcome in which all interventions will be included
that have a positive outcome on stimulating spontaneous breathing.

The design of this study is a single blinded randomized clinical trial.

For this study infants will be randomized to recurrent stimulation or standard
stimulation after birth.

Recurrent tactile stimulation is hereby defined as gently rubbing of the back
and the soles of the feet during 10 seconds. To prevent that the stimulatory
effect (reflex) will extinct every 10 seconds of stimulation will be followed
by 10 seconds without stimulation. The recurrent stimulation will take place in
the first 4 minutes after birth (from 0 until 240 seconds after birth).
Standard stimulation is conforming recommendation in the international
guidelines. Gently rubbing the back and the soles of the feet will be performed
when the clinicians consider the breathing to be insufficient or absent. After
4 minutes both groups are treated the same, stimulation can be given left to
the discretion of the caregiver.

The study is group-related, most preterm infants breathe at birth, but this is
often insufficient and respiratory support is needed. To minimise injury,
intubation and mechanical ventilation is now avoided and the focus of
respiratory care has shifted to non-invasive ventilation (positive pressure
support of breathing (CPAP) and/or ventilation via facemask). The most gentle
and effective way of providing respiratory care without causing injury is to
stimulate and support spontaneous breathing. In addition the benefit of
repetitive tactile stimulation is that it might increase respiratory effort,
while the risks are negligible when the stimulation is gently applied.