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

NCT05651035 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.14287
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Breastfeeding; Bottlefeeding; Premature

Keywords

preterm infants; oral feeding; breastfeeding; bottlefeeding; physiological parameters; test weighing; initial oral feeding; Neonatal Intensive Care Unit; Cue-Based oral feeding; Transition to oral feeding

Outcome Measures

Primary Outcomes (1)

• preterm infant's weight gain

  It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding.

  30 minutes before oral feeding and 30 minutes after oral feeding is complete

Secondary Outcomes (2)

• Oxygen saturation

  30 minutes

• Heart rate

  30 minutes

Study Arms (2)

Breastfeeding group

EXPERIMENTAL

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.

Other: oral feeding

Bottle-feeding group

NO INTERVENTION

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

Interventions

oral feeding 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.

Breastfeeding group

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
• Breastfed,

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

IstanbulUC

Avcılar, Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (11)

• Girgin BA, Gozen D, Karatekin G. Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial. J Spec Pediatr Nurs. 2018 Apr;23(2):e12214. doi: 10.1111/jspn.12214. Epub 2018 Mar 5.

  PMID: 29504676 BACKGROUND

• Chen CH, Wang TM, Chang HM, Chi CS. The effect of breast- and bottle-feeding on oxygen saturation and body temperature in preterm infants. J Hum Lact. 2000 Feb;16(1):21-7. doi: 10.1177/089033440001600105.

  PMID: 11138220 BACKGROUND

• Fontana C, Menis C, Pesenti N, Passera S, Liotto N, Mosca F, Roggero P, Fumagalli M. Effects of early intervention on feeding behavior in preterm infants: A randomized controlled trial. Early Hum Dev. 2018 Jun;121:15-20. doi: 10.1016/j.earlhumdev.2018.04.016. Epub 2018 May 3.

  PMID: 29730130 BACKGROUND

• Goldfield EC, Richardson MJ, Lee KG, Margetts S. Coordination of sucking, swallowing, and breathing and oxygen saturation during early infant breast-feeding and bottle-feeding. Pediatr Res. 2006 Oct;60(4):450-5. doi: 10.1203/01.pdr.0000238378.24238.9d. Epub 2006 Aug 28.

  PMID: 16940236 BACKGROUND

• Gianni ML, Sannino P, Bezze E, Comito C, Plevani L, Roggero P, Agosti M, Mosca F. Does parental involvement affect the development of feeding skills in preterm infants? A prospective study. Early Hum Dev. 2016 Dec;103:123-128. doi: 10.1016/j.earlhumdev.2016.08.006. Epub 2016 Aug 31.

  PMID: 27591506 BACKGROUND

• Rocha NM, Martinez FE, Jorge SM. Cup or bottle for preterm infants: effects on oxygen saturation, weight gain, and breastfeeding. J Hum Lact. 2002 May;18(2):132-8. doi: 10.1177/089033440201800204.

  PMID: 12033074 BACKGROUND

• Moral A, Bolibar I, Seguranyes G, Ustrell JM, Sebastia G, Martinez-Barba C, Rios J. Mechanics of sucking: comparison between bottle feeding and breastfeeding. BMC Pediatr. 2010 Feb 11;10:6. doi: 10.1186/1471-2431-10-6.

  PMID: 20149217 BACKGROUND

• Stevens EE, Gazza E, Pickler R. Parental experience learning to feed their preterm infants. Adv Neonatal Care. 2014 Oct;14(5):354-61. doi: 10.1097/ANC.0000000000000105.

  PMID: 25000100 BACKGROUND

• Thoyre SM, Pados BF, Shaker CS, Fuller K, Park J. Psychometric Properties of the Early Feeding Skills Assessment Tool. Adv Neonatal Care. 2018 Oct;18(5):E13-E23. doi: 10.1097/ANC.0000000000000537.

  PMID: 30239407 BACKGROUND

• Settle M, Francis K. Does the Infant-Driven Feeding Method Positively Impact Preterm Infant Feeding Outcomes? Adv Neonatal Care. 2019 Feb;19(1):51-55. doi: 10.1097/ANC.0000000000000577.

  PMID: 30672812 BACKGROUND

• Sabaz N, Gozen D, Tastekin A. Effects of breastfeeding and bottle feeding as the initial oral feeding on physiological parameters and feeding performance in preterm infants: A randomized controlled study. J Pediatr Gastroenterol Nutr. 2025 Nov 29. doi: 10.1002/jpn3.70295. Online ahead of print.

  PMID: 41318959 DERIVED

Related Links

• Assessment of Oral Feeding Readiness in Preterm Infants
• Evidence-Based Interventions Supporting Oral Feeding in Preterm Infants

MeSH Terms

Conditions

Premature Birth; Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Duygu Gözen, Ph.D.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant, PhD candidate

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 14, 2022
• Study Start: December 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)