Behavior, ChildKangarooNCT05165004
Effect of Kangaroo Mother Care Versus Hammock Positioning
A study testing Kangaroo Mother Care, Hammock Positioning and Routine Care of NICU in people with Behavior, Child, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child
- What is being tested?
- Kangaroo Mother Care, Hammock Positioning and Routine Care of NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2021to 23 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm Neonates
- Hemodynamically stable
Who cannot join
- Mechanically Ventilated
- Pulmonary Disorders
- Cardiac Disorders,
- Neurological Disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kangaroo Mother Care Versus Hammock Positioning on Physiological Indices and Behavioral Organization Among Preterm Neonates: A Humanized Nursing Approach
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.
Read the 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.
- Conditions
- Behavior, Child
- Being tested
- Kangaroo Mother Care, Hammock Positioning, Routine Care of NICU
- Keywords
- Kangaroo-Mother Care Method, Patient Positioning, Infant Behavior, Physiological, Premature, Neonatal Nursing
- Medical subject headings
- Child Behavior, Infant Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareBehavioural
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
Hammock PositioningBehavioural
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
Routine Care of NICUBehavioural
; encircling the neonate in a fetal position using rolled towel inside the incubator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Routine Care of NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonates' Heart Rate (HR)
The researchers recorded the neonates' heart rate from the ECG monitor
Measured: immediately after the intervention
Neonates' Respiratory Rate (RR)
The researchers recorded the neonates' Respiratory Rate (RR) the ECG monitor
Measured: immediately after the intervention
Neonates' Oxygen Saturation (SpO2)
The researchers recorded the neonates' oxygen saturation (SpO2) using the pulse oximetry
Measured: immediately after the intervention
Neonates' Temperature
The researchers measure the neonates' temperature using electronic thermometer
Measured: immediately after the intervention
Neonates' Weight
The researchers measure the neonates' weight using digital weighing scale
Measured: 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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start22 Feb 2021
- Primary completion19 Jul 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Eman m Taha, professor, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165004
- Sponsor's protocol ID
- 2218112020
- Acronym
- Kangaroo
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31493775Campbell-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.
PubMed 29388613Feldman 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.
PubMed 24094511Jesus 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.
PubMed 29598896Korraa 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.
PubMed 25391600Menger 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.
PubMed 33263617
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kangaroo Mother Care Versus Hammock Positioning on Physiological Indices and Behavioral Organization Among Preterm Neonates: A Humanized Nursing Approach
- ClinicalTrials.gov ID
- NCT05165004
- Acronym / sponsor ID
- Kangaroo / 2218112020
- Conditions
- Behavior, Child
- Keywords
- Kangaroo-Mother Care Method, Patient Positioning, Infant Behavior, Physiological, Premature, Neonatal Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Mother Care | Experimental | Behavioral: Kangaroo Mother CareResearchers 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. |
| Hammock Positioning | Experimental | Behavioral: Hammock PositioningResearchers 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. |
| NICU Routine Care | Active comparator | Behavioral: Routine Care of NICUThe 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. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm Neonates
- Hemodynamically stable
Key exclusion criteria (4 listed)
- Mechanically Ventilated
- Pulmonary Disorders
- Cardiac Disorders,
- Neurological Disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Mother Carethe 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 | Behavioural | Kangaroo Mother Care |
| Hammock PositioningAfter 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 | Behavioural | Hammock Positioning |
| Routine Care of NICU; encircling the neonate in a fetal position using rolled towel inside the incubator. | Behavioural | NICU Routine Care |
Primary outcome
Neonates' Heart Rate (HR)
Time frame: immediately after the intervention
The researchers recorded the neonates' heart rate from the ECG monitor
Neonates' Respiratory Rate (RR)
Time frame: immediately after the intervention
The researchers recorded the neonates' Respiratory Rate (RR) the ECG monitor
Neonates' Oxygen Saturation (SpO2)
Time frame: immediately after the intervention
The researchers recorded the neonates' oxygen saturation (SpO2) using the pulse oximetry
Neonates' Temperature
Time frame: immediately after the intervention
The researchers measure the neonates' temperature using electronic thermometer
Neonates' Weight
Time frame: 3 days After the intervention
The researchers measure the neonates' weight using digital weighing scale
Anderson Behavioral State Scale
Time frame: immediately after the intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 31493775El-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.
- Background: PubMed 29388613Campbell-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.
- Background: PubMed 24094511Feldman 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.
- Background: PubMed 29598896Jesus 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.
- Background: PubMed 25391600Korraa 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.
- Background: PubMed 33263617Menger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman m Taha, professor study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Mother Care, Hammock Positioning and Routine Care of NICU in people with Behavior, Child, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonates' Heart Rate (HR) (time frame: immediately after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05165004, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.