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Completed

NCT Number: NCT05957900

Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.

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Key information

Conditions

Preterm Neonates

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arafa

Alexandria, Egypt

About this study

This study will be conducted at Neonatal Intensive Care Unit (NICU) of Alexandria University Children's Hospital (AUCH) at Smouha, Alexandria, egypt.

A sample of 60 preterm neonates.The study subjects will be randomly assigned into two equal groups (control and multi-sensory stimulation groups) using random number table. Each group will be comprised of 30 neonates. The first neonate will be assigned to the control group and the second neonate will be assigned to the multi-sensory stimulation group.

Control group: Preterm neonates will receive only routine care of the unit. Multi-Sensory Stimulation group: Preterm neonates will receive multi-sensory stimulation intervention beside routine care of the unit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age ranges from 32 and 36 weeks.
  • The preterm infant's 5 min Apgar is 6 and more.

Exclusion criteria

  • History of cardiopulmonary resuscitation or surgery.
  • History of intraventricular hemorrhage grade II and above.
  • Major congenital malformations

Treatment and study plan

Multisensory stimulation module

Behavioral
  • Tactile Stimulation; Gentle stroking massage with moderate pressure, with warm palms for 3 min in a sequence of chest, upper limbs, and lower limbs in supine position.
  • Visual Stimulation; Black and white visual stimulation card hung at 8-10 in. from the neonate for 3 min.
  • Vestibular Stimulation; neonates placed in a hammock for 3 min.
  • Kinesthetic stimulation: It consist of passive exercises (flexion and extension) of upper and lower limbs; one of the hands support the stimulated limb, whereas the other hand will perform the movements for 3 min. in supine position.
  • Oral stimulation: the perioral structures will stroke by gently tapping the cheeks, lips and jaw by the index and middle finger for 2 min and stroking the intraoral structures by rubbing the gum and applying downward pressure of the tongue for 2 min. Non-nutritive sucking for 8 minutes.
  • Olfactory Stimulation for 3 min. using mother's milk.
  • Auditory Stimulation listening to mother's heart beats for 3 min.

Primary outcomes

  1. Change of Neurobehavioral responses of preterm neonates will be assessed after two weeks.

    Time frame: It will be assessed "baseline, pre-intervention within 24 hours. of admission and after two weeks of study to identify change.

    It was monitored using Neonatal Neurobehavioral Examination Scale (NNE). it is reliable and valid scale for assessing neurobehavioral development of neonates.It includes three main categories: tone and motor patterns, primitive reflexes, and behavioral responses. the total items of scale were 27, with total score ranged between 27 to 81, which high score means a better outcome and low score means a worse outcome.

Secondary outcomes

  1. Birth weight of preterm neonate

    Time frame: It will assessed initially before conducting the study.

    In kilograms

  2. Gestational age

    Time frame: It will assessed initially before conducting the study.

    / weeks. by new ballard scale.

  3. Apgar score at 1 and 5 minutes.

    Time frame: It will assessed initially before conducting the study.

    score

  4. Neonate's weight

    Time frame: It will assessed initially before conducting the study.

    n kilograms.

  5. Type of feeding.

    Time frame: It will assessed initially before conducting the study.

    NPO, oral, orogastric feeding

  6. amount of feeding.

    Time frame: It will assessed initially before conducting the study.

    / ml.

  7. Length of NICU stay

    Time frame: It will assessed initially before conducting the study.

    in days (date of discharge-date of admission).

  8. Neonate mother's age

    Time frame: It will assessed initially before conducting the study.

    in years.

  9. Residence.

    Time frame: It will assessed initially before conducting the study.

    Rural, urban areas

  10. Type of delivery.

    Time frame: It will assessed initially before conducting the study.

    Cesarean section, Normal Vaginal Delivery

  11. Number of gravida.

    Time frame: It will assessed initially before conducting the study.

    number

  12. Number of para.

    Time frame: It will assessed initially before conducting the study.

    number

  13. Number of abortion.

    Time frame: It will assessed initially before conducting the study.

    number

  14. Plurality.

    Time frame: It will assessed initially before conducting the study.

    number

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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