Viewing Study NCT05165004


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Study NCT ID: NCT05165004
Status: COMPLETED
Last Update Posted: 2021-12-21
First Post: 2021-11-25
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effect of Kangaroo Mother Care Versus Hammock Positioning
Sponsor: Alexandria University
Organization:

Study Overview

Official Title: Effect of Kangaroo Mother Care Versus Hammock Positioning on Physiological Indices and Behavioral Organization Among Preterm Neonates: A Humanized Nursing Approach
Status: COMPLETED
Status Verified Date: 2021-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Kangaroo
Brief Summary: Aim

This study aimed to investigate the effect of kangaroo mother care (KMC)versus hammock positioning (HP) on physiological indices and behavioral organization among preterm neonates.

Hypotheses

Preterm neonates who receive KMC exhibit more stable physiological indices and behavioral organization state than those who do not .

Preterm neonates who receive HP exhibit more stable physiological indices and behavioral organization state than those who do not .

Preterm neonates who receive KMC exhibit more stable physiological indices and behavioral organization state than those who receive HP.
Detailed Description: A quasi-experimental, pre-posttests, research design was carried out at the Neonatal Intensive Care Unit (NICU) of Specialized University Hospital . A sample of 90 preterm neonates were randomly assigned into three equal groups. The preterm neonates in the control group received the routine care of the NICU, which entails; encircling the neonate in a fetal position using rolled towel inside the incubator.

For the KMC group:

Researchers contacted the mother a day before applying KMC, and advised her to take shower and abstain from using perfumes before attending to the NICU. On days of KMC application, the researchers asked the mother to remove the upper clothes in a private room and put on an open-front gown and mask. The mother was assisted to sit in a comfortable chair with a soft backrest and footrest to prevent fatigue. Then, the preterm neonate was carefully put naked except for the head and diaper area on the mothers' bare chest with flexed arms and legs as in froglike position, and the head was turned sideways. The researchers wrapped and secured the mother's gown and put a blanket on the neonates' back to ensure neonatal thermal insulation. The mother was instructed to support the neonate's bottom with the right hand while supporting the head and neck with the other hand.

For HP group:

Researchers made a hammock by using a rectangular cotton cloth with ropes that passed through the circular openings of the incubator and tied on the upper part of it. After one hour of feeding, the preterm neonate was placed in a supine fetal position in the hammock where the head was supported in a neutral midline position by using rolled towel without neck hyperflexion or hyperextension. Moreover, the spine of the preterm neonate was supported while arms and knees were flexed.

Kangaroo mother care and HP were performed in the morning shift for one hour from 10 am till 11 am on three consecutive days. Behavioral states of preterm neonates were assessed in the three groups four times during the intervention at fixed intervals in order to minimize the measurement errors due to fluctuations in their behavioral states. In case of incidental neonatal distress, the intervention was discontinued. After one hour of applying KMC or HP, the preterm neonates were placed in the incubator as the routine NICU care. Finally, neonates' physiological indices and behavioral states in the three groups were recorded after 15 min from the intervention using tools I\&II. Data were collected over 12 months from March 2020 till the end of February 2021.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: