Pulsatile, audible, tactile stimulation for premature babies in neonatal intensive care units to reduce pain and increase weight gain

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN13554391
• Date of registration: 24/09/2015
• Prospective Registration: Yes
• Primary sponsor: Sociedad Peruana de Pediatría
• Public title: Pulsatile, audible, tactile stimulation for premature babies in neonatal intensive care units to reduce pain and increase weight gain
• Scientific title: Pulsatile, audible, tactile stimulation for premature infants in neonatal intensive care units to reduce pain and increase weight gain
• Date of first enrolment: 01/02/2016
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13554391
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Prevention)

Countries of recruitment

Peru

Contacts

• Name: Cynthia Anticona

• Name: Monica Pajuelo

Key inclusion & exclusion criteria

Inclusion criteria: 1. Medically stable
2. Gestational age between 30 and 33 weeks + 6 days
3. Birth weight between 1000 and 1400 grams
4. Weight at the time of recruitment > 1000 grams
5. Parental informed consent
Exclusion criteria: 1. APGAR score < 7 at 5 minutes.
2. Genetic abnormalities, gastrointestinal and cardiac birth defects, central nervous system birth defects, intrauterine growth retardation.
3. Diseases related to prematurity including: severe hyperbilirubinemia, grade III or IV intraventricular hemorrhage, necrotising enterocolitis, chronic lung disease.
4. Persistent infections or metabolic problems during hospitalization.
5. Maternal history of: alcohol or illicit drugs exposure, syphilis , hepatitis B , HIV and
other intrauterine infections .
6. Medical conditions that alter the body movement or the ability to participate in the
intervention, pathological fractures, bone deformities or seizures.
7. Outgoing or scheduled surgery within the first 28 days of life.
8. Use of sedatives or painkillers at the onset of the study or in the previous 72 hours.
9. Use of postnatal steroids.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Prematurity
Neonatal Diseases
Prematurity

Intervention(s)

Participants are randomly allocated into one of two groups:

Intervention group: Infants rest on a special incubator mattress called PATS for a period of 14 days. During this period, they will receive the pulsatile audible tactile stimulation (provided by the PATS mattress) for 9 hours per day, every other hour, starting at 6 am and ending at 12 pm (midnight).
The PATS is a low-cost mattress that provides a pulsatile audible-tactile stimulation (PATS). On its top side (the side which is in contact with the newborn), the mattress has a plastic pocket containing a water film. Through this water film, a vibration-producing device inserted in the mattress foam provides the tactile pulsatile stimulation. In addition, two small speakers located on the corners of the mattress will produce a record of sounds similar to the mother’s heartbeat. The range of sounds goes from 100 to 300 Hertz, which is the range of intrauterine audible perception. The sounds produced are less than 45 decibels as recommended by the American Academy of Pediatrics. The result is a pulsatile tactile audible stimulus. The stimulus duration is 25 hundredths of a second and the frequency is 60 per minute (similar to the normal heart rate of an adult at rest). The provision of the pulsatile audible tactile stimulation is controlled by an electronic system operated using a 12-volt rechargeable battery.

Control Group: Infants rest on a regular incubator mattress, and will be followed up for 14 days.

Primary Outcome(s)

Pain levels will be assessed from videos of each participant receiving venipuncture procedures using the Premature Infant Pain Profile (PIPP) scale, within the first three days of the intervention and then between days 12 and 14.

Secondary Outcome(s)

Weight gain will be measured daily over the 14 day intervention period at the same time by a NICU nurse using a calibrated neonatal scale.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Grand Challenges Canada, Fondecyt Peru