Clinical trial NCT05165004: Effect of Kangaroo Mother Care Versus Hammock Positioning
Official title: Effect of Kangaroo Mother Care Versus Hammock Positioning on Physiological Indices and Behavioral Organization Among Preterm Neonates: A Humanized Nursing Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Keywords: Kangaroo-Mother Care Method
Patient Positioning
Infant Behavior
Physiological
Premature
Neonatal Nursing
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Preterm Neonates
* Hemodynamically stable

Exclusion Criteria:

* Mechanically Ventilated
* Pulmonary Disorders
* Cardiac Disorders,
* Neurological Disorders

Primary outcomes:
measure: Neonates' Heart Rate (HR)
timeFrame: immediately after the intervention
measure: Neonates' Respiratory Rate (RR)
timeFrame: immediately after the intervention
measure: Neonates' Oxygen Saturation (SpO2)
timeFrame: immediately after the intervention
measure: Neonates' Temperature
timeFrame: immediately after the intervention
measure: Neonates' Weight
timeFrame: 3 days After the intervention
measure: Anderson Behavioral State Scale
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Alexandria University
name: Eman m Taha, professor
role: STUDY_CHAIR
References:
citation: El-Farrash RA, Shinkar DM, Ragab DA, Salem RM, Saad WE, Farag AS, Salama DH, Sakr MF. Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial. Pediatr Res. 2020 Mar;87(4):683-688. doi: 10.1038/s41390-019-0558-6. Epub 2019 Sep 7.
citation: Campbell-Yeo ML, Disher TC, Benoit BL, Johnston CC. Understanding kangaroo care and its benefits to preterm infants. Pediatric Health Med Ther. 2015 Mar 18;6:15-32. doi: 10.2147/PHMT.S51869. eCollection 2015.
citation: Feldman R, Rosenthal Z, Eidelman AI. Maternal-preterm skin-to-skin contact enhances child physiologic organization and cognitive control across the first 10 years of life. Biol Psychiatry. 2014 Jan 1;75(1):56-64. doi: 10.1016/j.biopsych.2013.08.012. Epub 2013 Oct 4.
citation: Jesus VR, Oliveira PMN, Azevedo VMGO. Effects of hammock positioning in behavioral status, vital signs, and pain in preterms: a case series study. Braz J Phys Ther. 2018 Jul-Aug;22(4):304-309. doi: 10.1016/j.bjpt.2018.03.002. Epub 2018 Mar 15.
citation: Korraa AA, El Nagger AA, Mohamed RA, Helmy NM. Impact of kangaroo mother care on cerebral blood flow of preterm infants. Ital J Pediatr. 2014 Nov 13;40:83. doi: 10.1186/s13052-014-0083-5.
citation: Menger JL, Mafaldo LR, Schiwe D, Schaan CW, Heinzmann-Filho JP. EFFECTS OF HAMMOCK POSITIONING ON CLINICAL PARAMETERS IN PRETERM INFANTS ADMITTED TO A NEONATAL INTENSIVE CARE UNIT: A SYSTEMATIC REVIEW. Rev Paul Pediatr. 2020 Nov 30;39:e2019399. doi: 10.1590/1984-0462/2021/39/2019399. eCollection 2020.