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InfantsNCT06447558

The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger"

A study testing palatal stimulation with a finger in premature infants in people with Infants, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to investigate the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with orogastric tube feeding. Read more about this study

Who is it for?
Ages 28 to 36 weeks
Conditions the study is for
Infants
What is being tested?
palatal stimulation with a finger in premature infants
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2021to 28 Jun 2022
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 28 to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Babies born between 28-36 weeks of birth
  • Premature babies without major congenital anomalies, severe systemic disorders, NEC, suspected or confirmed sepsis diagnosis
  • Premature babies whose vital importance is fixed
  • Babies who were not intubated at the time of the research

Who cannot join

  • Babies younger than 28 weeks of birth and older than 36 weeks of birth
  • Premature babies with major congenital anomalies, severe systemic disorders, NEC, suspected or confirmed sepsis diagnosis
  • Premature babies whose vital features are unstable
  • Babies who were intubated at the time of the research
  • Babies who do not have parental permission to work

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Medipol University

    Istanbul, Beykoz, 34810

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger" Methods on Feed Tolerance in Preterm Newborns Fed Via an Orogastric Tube

The aim of this study was to investigate the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with orogastric tube feeding.

This randomized controlled experimental study was conducted in the neonatal intensive care unit of a private hospital. The study included 90 premature newborns born at 28-36 weeks of gestation and admitted to the intensive care unit. The intervention group consisted of 60 infants and the control group consisted of 30 infants. "Demographic Information Form" and "Patient Follow-up Form" were used to collect data. Data collection tools were used before, during and after the procedures in all groups. In one of the intervention groups, breast milk droplets were applied to the oral cavity of the newborns, and in the other group, the palate of the newborns was stimulated using a finger. These interventions were performed for 5 minutes every 3 hours for 7 days during the newborns' feeding times. Neonates in the control group were fed with an orogastric tube by following hygiene rules, but no study intervention was performed in these infants. SPSS (Statistical Package for Social Sciences) 22.0 for Windows software was used for statistical analysis.

Read the detailed description

This is a randomized, controlled and experimental study investigating the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" methods on feeding tolerance in infants fed with an orogastric tube.The study included 90 premature infants who were 28-36 weeks of gestation, admitted to the neonatal intensive care unit and whose parents consented to participate. Two intervention groups (Intervention1 and Intervention2) consisted of a total of 60 infants and the control group consisted of 30 infants. A power analysis was conducted to calculate the number of premature infants to be included in the study. We created the randomization table using the instructions in the following link: "https://www.calculatorsoup". The study was completed with 90 newborns who met the inclusion criteria and whose parents consented to participate. Of these newborns, 60 were in the intervention group and 30 were in the control group. Data were collected using the "Demographic Information Form" and "Patient Follow-up Form" developed by the researcher in line with the literature.

Study Execution

Pre-Procedure: The steps before the procedure were the same for each group, i.e. the oral administration of breast milk droplets group, the palatal stimulation group and the control group. Before the procedure, the subjects' identities were checked and the Demographic Information Form (gender, gestational week, birth weight, head circumference and height) and Patient Follow-up Form were completed. The newborns in all groups were placed on an orogastric tube, positioned, and finally the infants' heads were gently lifted from the bed at a 30-degree angle. After achieving the correct position, their remains were checked and the results were noted. The stomachs of all premature infants included in the study were checked every 3 hours before feeding for 7 days.

Sequence of Procedures: Infants in the oral administration of breast milk droplets group were fed with an oroastric catheter after a total of 0.5 cc of breast milk was administered in drops using an insulin syringe for 5 minutes. In the palatal stimulation group, the palate and gums were stimulated with slow and peristalsis-like movements for 5 minutes with the gloved pinky finger of one hand while the infants were fed with an orogastric catheter, following the necessary hygiene rules. Premature infants in the control group were fed with orogastric catheter by following all hygiene rules, but no intervention was performed. Intervention groups received intervention for 5 minutes every 3 hours during feeding hours for 7 days.

Post Procedure: After feeding, all infants received routine comfort care, including diaper care, positioning, and environmental adjustments (adjusting sound and light levels, etc.). After routine comfort care, defecation was examined in all subjects every day during the 7-day follow-up period and the results were recorded. At the end of each day, the abdominal circumference and body weight of the newborns were measured and the measurements were noted on the forms. SPSS (Statistical Package for Social Sciences) 22.0 for Windows software was used for statistical analysis. Number, percentage, mean and standard deviation were used in descriptive statistical methods. Differences between the rates of categorical variables in independent groups were analyzed using the chi-square test and Fisher's exact test. One-way Analysis of Variance was used to compare quantitative continuous data between groups. Repeated Measures ANOVA Test was used for within-group comparisons.

Conditions
Infants
Being tested
palatal stimulation with a finger in premature infants
Keywords
Breast milk, Palatal stimulation with a finger

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • palatal stimulation with a finger in premature infantsBehavioural

    Oral administration of breast milk droplets, palatal stimulation with a finger in premature infants

Study groups in NCT06447558
Study groupRoleWhat they receive
Breast milk droplets groupNo interventionWe fed the infants via OGT in the oral administration of breast milk droplets group after applying a total of 0.5 cc of breast milk in drops into their mouths for 5 minutes by using an insulin injector.Breast milk droplets group was 30 infants
Palatal stimulation groupOtherIn the palatal stimulation group, following the necessary hygiene rules, we used the little finger of one of our hands with a glove on and stimulated the palate and gums of the infants with this finger by slow and peristalsis-like movements for 5 minutes while the infants were fed via OGT. Palatal stimulation group was 30 infants.
Receives: Behavioral: palatal stimulation with a finger in premature infants
Control groupNo interventionWe fed the premature infants in the control group via OGT following all hygiene rules, but we performed no intervention. In the intervention groups, where we orally applied breast milk in droplets in one group and stimulated the palate of the newborns by using a finger in the other, we performed these interventions every 3 hours for 5 minutes for 7 days at feeding times.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Defecation

    The number of daily defecations was monitored

    Measured: 7 days

  2. Residual control

    Daily residue count was monitored

    Measured: 7 days

  3. Body weight

    Body weight checked daily

    Measured: 7 days

  4. Abdominal circumference measurement

    Abdominal circumference was measured daily

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start1 May 2021
  3. Primary completion25 Mar 2022
  4. Study completion28 Jun 2022

Resources

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
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06447558
Sponsor's protocol ID
E-10840098-772.02-4979
Status last verified
Jun 2024
First submitted
20 Apr 2024
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing palatal stimulation with a finger in premature infants in people with Infants, run by Istanbul Medipol University Hospital 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 4 inclusion and 5 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 7 Jun 2024. 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?

Defecation (time frame: 7 days). The study lists 4 primary outcomes in all. 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 7 Jun 2024.

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