- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05491265
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Sign and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Signs and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit : A Randomized Controlled Trail
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.
Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.
The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dr Maimoona Saeed, MBBS
- Telefonnummer: 00923165415720
- E-mail: dr.maimoona@live.com
Undersøgelse Kontakt Backup
- Navn: Dr Syeda Shireen Gul, MBBS,FCPS
- Telefonnummer: 00923002263969
- E-mail: syedashireengul@gmail.com
Studiesteder
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Islamabad, Pakistan, 46000
- Rekruttering
- Pakistan Institute Of Medical Sciences
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Ledende efterforsker:
- Dr Maimoona Saeed, MBBS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Birth weight between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems
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Exclusion Criteria:
Extreme preterm<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or >37 weeks
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Kangaroo mother care
To see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate.
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Skin to skin contact between mother and preterm newborn between gestational age 28 weeks to 36+6 weeks for three sessions per day ,each contact session of two hours .
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Ingen indgriben: standard of care
To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Temperature
Tidsramme: 2 hours
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To measure temperature difference in babies provided with kangaroo mother care vs incubator care
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2 hours
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Heart rate
Tidsramme: 2 hours
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To measure heart rate variations in babies provided with kangaroo mother care vs incubator care
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2 hours
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Oxygen Saturation
Tidsramme: 2 hours
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To measure oxygen saturation in babies provided with kangaroo mother care vs
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2 hours
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dr Maimoona Saeed, MBBS, Shaheed Zulfiqar Ali Bhutto Medical University
- Studiestol: Dr Fibhaa Syed, MBBS,FCPS, Shaheed Zulfiqar Ali Bhutto Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- F.1-1/2015/ERB/SZABMU/955
Plan for individuelle deltagerdata (IPD)
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