NCT05165004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

November 25, 2021

Last Update Submit

December 8, 2021

Conditions

Keywords

Kangaroo-Mother Care MethodPatient PositioningInfant BehaviorPhysiologicalPrematureNeonatal Nursing

Outcome Measures

Primary Outcomes (6)

  • Neonates' Heart Rate (HR)

    The researchers recorded the neonates' heart rate from the ECG monitor

    immediately after the intervention

  • Neonates' Respiratory Rate (RR)

    The researchers recorded the neonates' Respiratory Rate (RR) the ECG monitor

    immediately after the intervention

  • Neonates' Oxygen Saturation (SpO2)

    The researchers recorded the neonates' oxygen saturation (SpO2) using the pulse oximetry

    immediately after the intervention

  • Neonates' Temperature

    The researchers measure the neonates' temperature using electronic thermometer

    immediately after the intervention

  • Neonates' Weight

    The researchers measure the neonates' weight using digital weighing scale

    3 days After the intervention

  • Anderson Behavioral State Scale

    This scale was adopted from Anderson et al. (1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral state is judged by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is in a sleep state. Scores from 6 to 8 denotes that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a restless state of or fussiness.

    immediately after the intervention

Study Arms (3)

Kangaroo Mother Care

EXPERIMENTAL

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.

Behavioral: Kangaroo Mother Care

Hammock Positioning

EXPERIMENTAL

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.

Behavioral: Hammock Positioning

NICU Routine Care

ACTIVE COMPARATOR

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.

Behavioral: Routine Care of NICU

Interventions

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

Kangaroo Mother Care

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

Hammock Positioning

; encircling the neonate in a fetal position using rolled towel inside the incubator.

NICU Routine Care

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preterm Neonates
  • Hemodynamically stable

You may not qualify if:

  • Mechanically Ventilated
  • Pulmonary Disorders
  • Cardiac Disorders,
  • Neurological Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 56321, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 31493775BACKGROUND
  • 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.

    PMID: 29388613BACKGROUND
  • 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.

    PMID: 24094511BACKGROUND
  • 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.

    PMID: 29598896BACKGROUND
  • 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.

    PMID: 25391600BACKGROUND
  • 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.

    PMID: 33263617BACKGROUND

MeSH Terms

Conditions

Child BehaviorInfant BehaviorPremature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

BehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eman m Taha, professor

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 21, 2021

Study Start

February 22, 2021

Primary Completion

July 19, 2021

Study Completion

July 23, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations