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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13554391

Enrollment

120

Registered

2015-09-24

Start date

2016-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity Neonatal Diseases Prematurity

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Peru

Contacts

Public ContactCynthia ;Monica Anticona;Pajuelo

;

cynthiaanticona@hotmail.com;mjpajuelo@gmail.com+51 988 855083;+51 994 670488

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026