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NCT Number: NCT06706115

Effect of Intranasal Breast Milk Administration in Preterm Infants

The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.

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Key information

Conditions

Newborn; Vitality Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Nursing Caries Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sibel Küçükoğlu, Prof

CONTACT

[email protected]

About this study

Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Birth weight >1000 gr,
  • APGAR score >7 at 5 minutes after birth,
  • Availability of breast milk,
  • No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
  • No congenital anomalies or chromosomal abnormalities,
  • No congenital anomaly (such as cleft palate) affecting nasal patency.

Exclusion criteria

  • Being able to feed orally in all feedings
  • Being fed entirely on formula milk,
  • Administration of medication via the nasal route,
  • Being intubated or receiving continuous positive air pressure (CPAP) support,
  • Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
  • The mother has mastitis, breast trauma, abscesses or is taking any medication that passes into the milk,
  • The mother does not want to express milk.

Treatment and study plan

Intranasal human breast milk

Other

The information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00).

Primary outcomes

  1. Infant Information Form

    Time frame: First measurement-First day of hospitalization

    The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)

  2. Physiologic Parameter Follow-up Form-Cerebral rSO2

    Time frame: First measurement- 5 minutes before the intervention (T0)

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

  3. Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)

    Time frame: First measurement- 5 minutes before the intervention (T0)

    Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

  4. Physiologic Parameter Follow-up Form-Heart Rate (HR)

    Time frame: First measurement- 5 minutes before the intervention (T0)

    Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

  5. Physiologic Parameter Follow-up Form-Respiratory rate

    Time frame: First measurement- 5 minutes before the intervention (T0)

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

  6. Nutrition Follow-up Form-intranasal breast milk content

    Time frame: First measurement- intranasal breast milk content

    Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.

Secondary outcomes

  1. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Time frame: Second measurement- 5. minutes after the intervention (T1)

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

  2. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Time frame: Second measurement- 15. minutes after the intervention (T1)

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

  3. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Time frame: Second measurement- 30. minutes after the intervention (T1)

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

  4. Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

    Time frame: Second measurement- 5. minutes after the intervention (T1)

    Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

  5. Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

    Time frame: Second measurement- 15. minutes after the intervention (T1)

    Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

  6. Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

    Time frame: Second measurement- 30. minutes after the intervention (T1)

    Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

  7. Physiologic Parameter Follow-up Form -Heart Rate (HR)

    Time frame: Second measurement- 5. minutes after the intervention (T1)

    Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

  8. Physiologic Parameter Follow-up Form -Heart Rate (HR)

    Time frame: Second measurement- 15. minutes after the intervention (T1)

    Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

  9. Physiologic Parameter Follow-up Form -Heart Rate (HR)

    Time frame: Second measurement- 30. minutes after the intervention (T1)

    Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

  10. Physiologic Parameter Follow-up Form -Respiratory rate

    Time frame: Second measurement- 5. minutes after the intervention (T1)

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

  11. Physiologic Parameter Follow-up Form -Respiratory rate

    Time frame: Second measurement- 15. minutes after the intervention (T1)

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

  12. Physiologic Parameter Follow-up Form -Respiratory rate

    Time frame: Second measurement- 30. minutes after the intervention (T1)

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

  13. Nutrition Follow-up Form-Nutrient content

    Time frame: Second measurement-Nutrient content

    Nutrient content (exclusive breast milk/formula+ breast milk feeding) in the Nutrition Follow-up Form will be recorded 5 minutes after the intervention.

  14. Nutrition Follow-up Form-Number of vomits

    Time frame: Second measurement- Number of vomits

    Number of vomits in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

  15. Nutrition Follow-up Form-Number of defecations

    Time frame: Second measurement- Number of defecations

    Number of defecations in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

  16. Nutrition Follow-up Form-The time of transition to full oral feeding

    Time frame: Second measurement- The time of transition to full oral feeding

    The time of transition to full oral feeding, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.

  17. Nutrition Follow-up Form-Discharge time

    Time frame: Second measurement- Discharge time

    Discharge time, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.

Study contacts

Contact information is provided by the study sponsor or research team.

Adalet Yücel, Assistant

CONTACT

[email protected]

+903322230770

Sibel Kucukoglu, Prof

CONTACT

[email protected]

+903322230789 ext. 31623

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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