Breastfeeding and Bottle Feeding: Impact on Preterm Infants' Physiology and Feeding Performance

NCT ID: NCT05651035

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this clinical trial is to evaluate the effect of breastfeeding on the infant's test weight and physiological characteristics (oxygen saturation and heart rate) in preterm infants in the Neonatal Intensive Care Unit during the transition to oral feeding.

The main question it aims to answer are:

• Is there a difference in test weight and physiological parameters between the infants in whom the first oral feeding was performed by the mother and the infants in whom the first oral feeding was performed by the intensive care unit nurse with a bottle? Researchers will compare the breastfed group with the bottle-fed group to see if there are differences in test weight and physiological parameters.

Detailed Description

In the pre-feeding stage of the research, the parents of the preterms included in the sample will be met and informed about the research. Written and verbal consent will be obtained from parents who agreed to participate in the study. "Preterm Infants Information Form" will be filled by the researcher before feeding and "Feeding Monitoring Form" will be filled during feeding. By randomization, it will be determined which of the experimental and control groups the preterm infant will be assigned to. It will be ensured that the interventions that will affect the vital signs of the preterms in both groups before feeding are not applied. Oxygen saturation and heart rate will be monitored for 30 minutes before, during and after feeding for all groups. Preterms in both groups will be dressed in clean and dry diapers by cleaning their bottoms before feeding, and will be weighed naked with a digital baby scale by removing their clothes. Weighing the preterms with an electronic precision balance before and after feeding - the test weighing - will be used to measure the amount of milk the preterm is expressing from the breast or bottle. The preterm will then be fed loosely wrapped in a cotton blanket. If the oxygen saturation level of all preterm infants falls below 90% during feeding, it will be considered desaturated and the feeding will be stopped. The preterm infants will continue to be fed when the oxygen saturation is ≥ 90% and the heart rate is 120-160/min. Feeding will be limited to a total of 30 minutes for infants in both groups, including rest intervals, and will not take longer. When the feeding is complete, preterms in both groups will be weighed naked without changing the diaper under the feeding process. It will be ensured that interventions that may affect the vital signs of all preterms included in the study are not applied when feeding is completed. The oxygen saturation and heart rate of the preterms in both groups will be monitored for 30 minutes after the feeding is completed. When feeding is complete, preterms in both groups will be placed on the same mother's breast in the right lateral position to facilitate gastric emptying.

Conditions

Preterm; Breastfeeding; Bottlefeeding; Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Breastfeeding group

Preterm infants in this group are breastfed by their mothers during their first oral feeding. Before, during and after feeding, the preterm infant's oxygen saturation level and peak heart rate are measured for 30 minutes. In addition, the test test weighing is determined by weighing the baby before and after feeding.

Group Type: EXPERIMENTAL

oral feeding

Intervention Type: OTHER

In experimental group infants: Preterms in this group will be breastfed by their own mother.

In control group infants: Preterms in this group will be fed by the researcher by putting the baby's own mother's milk in the bottle. During feeding, the preterm will be placed on the lap by the researcher in a standing position on the same mother's breast, and will be given a raised side-lying position. In this position, the preterm's head and body will be elevated 45-60 degrees with the help of a small pillow. While the researcher will support the preterm's head, neck and shoulder with one hand, he will control the bottle with the other hand. By touching the preterm's nipple to the preterm's lips, the preterm will be prepared for feeding, and the bottle will be placed in the baby's mouth with the mouth opening and the tongue lowering. During feeding, stimulating movements such as pushing the bottle back and forth in the mouth, which will lead the newborn to suck faster, will not be made.

Bottle-feeding group

Preterm infants in this group are fed with their mother's milk in the bottle during their first oral feeding.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

oral feeding

In experimental group infants: Preterms in this group will be breastfed by their own mother.

In control group infants: Preterms in this group will be fed by the researcher by putting the baby's own mother's milk in the bottle. During feeding, the preterm will be placed on the lap by the researcher in a standing position on the same mother's breast, and will be given a raised side-lying position. In this position, the preterm's head and body will be elevated 45-60 degrees with the help of a small pillow. While the researcher will support the preterm's head, neck and shoulder with one hand, he will control the bottle with the other hand. By touching the preterm's nipple to the preterm's lips, the preterm will be prepared for feeding, and the bottle will be placed in the baby's mouth with the mouth opening and the tongue lowering. During feeding, stimulating movements such as pushing the bottle back and forth in the mouth, which will lead the newborn to suck faster, will not be made.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks,
• Postmenstrual week at the time of the study was 32-36+6 weeks,
• Having a body weight of 1500 grams or more at the time of inclusion in the study,
• Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
• Breastfed,
• Preterm infants whose parents' consent was obtained for inclusion in the study and whose parents signed the informed consent form

Exclusion Criteria

• Receiving oxygen,
• Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis,
• Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases)

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Nagihan Sabaz

Principal Investigator, Research Assistant, PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duygu Gözen, Ph.D.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

IstanbulUC

Avcılar, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Related Links

https://www.turkiyeklinikleri.com/article/tr-preterm-bebeklerde-oral-beslenmeye-hazir-oluslugun-degerlendirilmesi-78966.html

Assessment of Oral Feeding Readiness in Preterm Infants

https://dergipark.org.tr/en/pub/clinexphealthsci/issue/35066/389077

Evidence-Based Interventions Supporting Oral Feeding in Preterm Infants

Other Identifiers

10840098-604.01.01-E.14287

Identifier Type: -

Identifier Source: org_study_id