Premature InfantsKangarooCareNCT05492747
Kangaroo Care an EffectonTransitionTime From Gavage Feeding
A study testing Kangaroo Care an Effect in people with Premature Infants, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage. Methods: This is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 27 to 36 weeks
- Conditions the study is for
- Premature Infants
- What is being tested?
- Kangaroo Care an Effect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2019to 5 Nov 2019
- 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 27 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents who agreed to participate in the study
Who cannot join
- healthy newborn
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Kangaroo Care Have an Effect on Transition Time From Gavage Feeding to Full Oral Feeding in Premature Babies?
Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage.
Methods: This is a randomized controlled trial. This study was conducted in a level III neonatal intensive care unit of a university hospital in eastern Turkey 50 premature babies with a birth weight of ≥ 1000 g and a gestational age of 27-36 weeks, and their mothers were included in the study. The cases were randomly divided into two groups: kangaroo care, which would be applied up to five days a week, and standard care. Records of cases were kept regularly from their hospitalization until they reached full oral feeding.
Read the detailed description
Study interventions i] Training: One day before starting the study, mothers in the kangaroo group were informed about kangaroo care. The training was provided in a meeting room outside the NICU. In the training, the advantages of the kangaroo care method for the mother and the baby and how the method will be applied were explained to the mothers. After the PowerPoint presentation, the mothers' questions were answered and they were given a kangaroo care guide prepared by the World Health Organization (WHO) [19].The training took about an hour. The researcher who provided the training is experienced in neonatal nursing and has a doctorate in pediatric nursing.
ii] Preparation of breast milk: The milks that the mothers milked and brought with storage bags were stored frozen below -18 degrees Celsius in the deep freezer of the food preparation room outside the NICU. These frozen milks were warmed by neonatal nurses according to the needs of the baby and given by syringe.
iii] Kangaroo care: Researchers observed vital signs and oxygen saturation of preterm infants in the kangaroo care group just before and during the kangaroo contact with the mother. After the baby's mother was admitted to the NICU, she was assisted by the researchers for hand hygiene and they went to the incubator together. The mother was seated in a comfortable chair next to the incubator. After the researchers covered the head and back of the preterm baby with a baby blanket, she took it from the incubator and placed it between the mother's breasts, with the head up and upright. The baby was supported not only by the neck and shoulders, but also by the whole body. Skin contact between mother and baby was ensured at the highest level. The baby was positioned so that its lips were touching the mother's nipple. The researchers waited until the baby opened its mouth. The baby's upper and lower lips were placed in such a way that the entire areola was in its mouth. The mother held her breast in a "C" shape with her hand. Thus, the baby's nose was prevented from being blocked. During the application, the researcher gave breast milk in the syringe to the baby through gavage. The babies and their mothers were observed by the researcher throughout the application. Kangaroo care was applied to the infants for 15-20 minutes during feeding, four times a day, five days a week. Kangaroo care of preterm infants fed by gavage continued until they achieved full oral feeding. Kangaroo care was also given to the babies who were connected to the ventilator.
iv] Standard care: Premature babies in this group were fed by gavage in the incubator. In standard neonatal care, parents could see their babies outside the incubator for 15-20 minutes. If parents want to touch their baby, they can do so through the open windows of the incubator, provided they wash their hands. Babies had only diapers and parents only touched their babies' hands, feet, back and abdomen without skin-to-skin contact. Ventilated premature babies are not placed on their parents' lap in accordance with NICU protocol.
v] Transition from gavage feeding to full oral feeding: The first feeding of preterm babies is usually made through the orogastric tube due to the incomplete development of sucking and swallowing reflexes and the immaturity of the gastrointestinal tract. Accordingly, premature babies included in the study were fed with an orogastric tube after a certain period of time after their hospitalization. Recordings were made daily and continued until the transition to full oral feeding was achieved.
- Conditions
- Premature Infants
- Being tested
- Kangaroo Care an Effect
- Keywords
- Gavage feeding, Kangaroo care, Oral feeding, Preterm babies
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Care an EffectOther
Researchers evaluated vital signs and oxygen saturation of preterm infants in the kangaroo care group 15 minutes before kangaroo care. After the baby's mother was admitted to the NICU, she was assisted by the researcher for hand hygiene and they went to the incubator together. The mother was seated in a comfortable chair next to the incubator. After the researcher covered the head and back of the preterm baby with a baby blanket, she took it from the incubator and placed it between the mother's breasts, with the head up and upright. The baby was supported not only by the neck and shoulders, but also by the whole body. Skin contact between mother and baby was ensured at the highest level. The baby was positioned so that its lips were touching the mother's nipple. The researcher waited until the baby opened its mouth.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Care Effects on Feeding | Experimental | The researcher allocated the mothers blindly. Eligible mothers and their preterm babies were randomized to either the kangaroo care group or the standard care group (1:1) (Figure 1). The mothers' surnames were written and put in a bag. The surnames were drawn from the bag by lot. The lots were drawn by a neonatal nurse. Neonatal nurse is a research independent person. The first drawn surname was included in the kangaroo group, while the next one was included in the control group, respectively. Receives: Other: Kangaroo Care an Effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
this study was measured the effects of kangaroo care in the transition period of preterm infants fed by gavage to full oral feeding.
Transition from gavage feeding to full oral feeding: The first feeding of preterm babies is usually made through the orogastric tube due to the incomplete development of sucking and swallowing reflexes and the immaturity of the gastrointestinal tract. Accordingly, premature babies included in the study were fed with an orogastric tube after a certain period of time after their hospitalization. Recordings were made daily and continued until the transition to full oral feeding was achieved.
Questionnaire for switching to full oral feeding: It is a questionnaire in which the date of transition to full feeding of preterm infants is written.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start3 Jan 2019
- Primary completion28 Jan 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM COŞKUN ŞİMŞEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492747
- Sponsor's protocol ID
- Kangaroo Care on Oral Feeding
- Acronym
- KangarooCare
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Kangaroo Care Have an Effect on Transition Time From Gavage Feeding to Full Oral Feeding in Premature Babies?
- ClinicalTrials.gov ID
- NCT05492747
- Acronym / sponsor ID
- KangarooCare / Kangaroo Care on Oral Feeding
- Conditions
- Premature Infants
- Keywords
- Gavage feeding, Kangaroo care, Oral feeding, Preterm babies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 8 Aug 2022 (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.
Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage.
Methods: This is a randomized controlled trial. This study was conducted in a level III neonatal intensive care unit of a university hospital in eastern Turkey 50 premature babies with a birth weight of ≥ 1000 g and a gestational age of 27-36 weeks, and their mothers were included in the study. The cases were randomly divided into two groups: kangaroo care, which would be applied up to five days a week, and standard care. Records of cases were kept regularly from their hospitalization until they reached full oral feeding.
Detailed description
Study interventions i] Training: One day before starting the study, mothers in the kangaroo group were informed about kangaroo care. The training was provided in a meeting room outside the NICU. In the training, the advantages of the kangaroo care method for the mother and the baby and how the method will be applied were explained to the mothers. After the PowerPoint presentation, the mothers' questions were answered and they were given a kangaroo care guide prepared by the World Health Organization (WHO) [19].The training took about an hour. The researcher who provided the training is experienced in neonatal nursing and has a doctorate in pediatric nursing.
ii] Preparation of breast milk: The milks that the mothers milked and brought with storage bags were stored frozen below -18 degrees Celsius in the deep freezer of the food preparation room outside the NICU. These frozen milks were warmed by neonatal nurses according to the needs of the baby and given by syringe.
iii] Kangaroo care: Researchers observed vital signs and oxygen saturation of preterm infants in the kangaroo care group just before and during the kangaroo contact with the mother. After the baby's mother was admitted to the NICU, she was assisted by the researchers for hand hygiene and they went to the incubator together. The mother was seated in a comfortable chair next to the incubator. After the researchers covered the head and back of the preterm baby with a baby blanket, she took it from the incubator and placed it between the mother's breasts, with the head up and upright. The baby was supported not only by the neck and shoulders, but also by the whole body. Skin contact between mother and baby was ensured at the highest level. The baby was positioned so that its lips were touching the mother's nipple. The researchers waited until the baby opened its mouth. The baby's upper and lower lips were placed in such a way that the entire areola was in its mouth. The mother held her breast in a "C" shape with her hand. Thus, the baby's nose was prevented from being blocked. During the application, the researcher gave breast milk in the syringe to the baby through gavage. The babies and their mothers were observed by the researcher throughout the application. Kangaroo care was applied to the infants for 15-20 minutes during feeding, four times a day, five days a week. Kangaroo care of preterm infants fed by gavage continued until they achieved full oral feeding. Kangaroo care was also given to the babies who were connected to the ventilator.
iv] Standard care: Premature babies in this group were fed by gavage in the incubator. In standard neonatal care, parents could see their babies outside the incubator for 15-20 minutes. If parents want to touch their baby, they can do so through the open windows of the incubator, provided they wash their hands. Babies had only diapers and parents only touched their babies' hands, feet, back and abdomen without skin-to-skin contact. Ventilated premature babies are not placed on their parents' lap in accordance with NICU protocol.
v] Transition from gavage feeding to full oral feeding: The first feeding of preterm babies is usually made through the orogastric tube due to the incomplete development of sucking and swallowing reflexes and the immaturity of the gastrointestinal tract. Accordingly, premature babies included in the study were fed with an orogastric tube after a certain period of time after their hospitalization. Recordings were made daily and continued until the transition to full oral feeding was achieved.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care Effects on Feeding | Experimental | Other: Kangaroo Care an EffectThe researcher allocated the mothers blindly. Eligible mothers and their preterm babies were randomized to either the kangaroo care group or the standard care group (1:1) (Figure 1). The mothers' surnames were written and put in a bag. The surnames were drawn from the bag by lot. The lots were drawn by a neonatal nurse. Neonatal nurse is a research independent person. The first drawn surname was included in the kangaroo group, while the next one was included in the control group, respectively. |
Who may qualify
- Ages
- 27 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents who agreed to participate in the study
Key exclusion criteria (2 listed)
- healthy newborn
- congenital anomalies
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 Care an EffectResearchers evaluated vital signs and oxygen saturation of preterm infants in the kangaroo care group 15 minutes before kangaroo care. After the baby's mother was admitted to the NICU, she was assisted by the researcher for hand hygiene and they went to the incubator together. The mother was seated in a comfortable chair next to the incubator. After the researcher covered the head and back of the preterm baby with a baby blanket, she took it from the incubator and placed it between the mother's breasts, with the head up and upright. The baby was supported not only by the neck and shoulders, but also by the whole body. Skin contact between mother and baby was ensured at the highest level. The baby was positioned so that its lips were touching the mother's nipple. The researcher waited until the baby opened its mouth. | Other | Kangaroo Care Effects on Feeding |
Primary outcome
this study was measured the effects of kangaroo care in the transition period of preterm infants fed by gavage to full oral feeding.
Time frame: 3 weeks
Transition from gavage feeding to full oral feeding: The first feeding of preterm babies is usually made through the orogastric tube due to the incomplete development of sucking and swallowing reflexes and the immaturity of the gastrointestinal tract. Accordingly, premature babies included in the study were fed with an orogastric tube after a certain period of time after their hospitalization. Recordings were made daily and continued until the transition to full oral feeding was achieved. Questionnaire for switching to full oral feeding: It is a questionnaire in which the date of transition to full feeding of preterm infants is written.
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 29 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Care an Effect in people with Premature Infants, run by Firat University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 29 Aug 2022. 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 Turkey (Türkiye). 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?
this study was measured the effects of kangaroo care in the transition period of preterm infants fed by gavage to full oral feeding. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2022.