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Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms

Primary Purpose

Premature, Breast Feeding, Bottle Feeding

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral feeding
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Premature focused on measuring preterm infants, oral feeding, breastfeeding, bottle-Feeding, physiological parameters

Eligibility Criteria

32 Weeks - 39 Weeks (Child)All SexesAccepts Healthy Volunteers

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 32-39+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)

Sites / Locations

  • IstanbulUCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breastfeeding group

Bottle-feeding group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oxygen saturation
Oxygen saturation ≥ 90% during and just after oral feeding
Heart rate
Heart rate 120-160/min during and just after oral feeding

Full Information

First Posted
November 29, 2022
Last Updated
December 6, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05651035
Brief Title
Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms
Official Title
Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Breast Feeding, Bottle Feeding
Keywords
preterm infants, oral feeding, breastfeeding, bottle-Feeding, physiological parameters

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding group
Arm Type
Experimental
Arm Description
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.
Arm Title
Bottle-feeding group
Arm Type
No Intervention
Arm Description
Preterm infants in this group are fed with their mother's milk in the bottle during their first oral feeding.
Intervention Type
Other
Intervention Name(s)
oral feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
preterm infant's weight gain
Description
It is to determine the weight gain by weighing the preterm infant with the same diaper before and after oral feeding.
Time Frame
30 minutes before oral feeding and 30 minutes after oral feeding is complete
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Oxygen saturation ≥ 90% during and just after oral feeding
Time Frame
30 minutes
Title
Heart rate
Description
Heart rate 120-160/min during and just after oral feeding
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
39 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 32-39+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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagihan Sabaz, MSc
Phone
+905319468677
Email
nagihan.semin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Gözen, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
IstanbulUC
City
Avcılar
State/Province
Istanbul
ZIP/Postal Code
34320
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duygu Gözen, PhD
First Name & Middle Initial & Last Name & Degree
Nagihan Sabaz, MSc
Phone
+905319468677
Email
nagihan.semin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29504676
Citation
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.
Results Reference
result
PubMed Identifier
11138220
Citation
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.
Results Reference
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PubMed Identifier
29730130
Citation
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.
Results Reference
result
PubMed Identifier
16940236
Citation
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.
Results Reference
result
PubMed Identifier
27591506
Citation
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.
Results Reference
result
PubMed Identifier
12033074
Citation
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.
Results Reference
result
PubMed Identifier
20149217
Citation
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.
Results Reference
result
PubMed Identifier
25000100
Citation
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.
Results Reference
result
PubMed Identifier
30239407
Citation
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.
Results Reference
result
PubMed Identifier
30672812
Citation
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.
Results Reference
result
Links:
URL
https://www.turkiyeklinikleri.com/article/tr-preterm-bebeklerde-oral-beslenmeye-hazir-oluslugun-degerlendirilmesi-78966.html
Description
Assessment of Oral Feeding Readiness in Preterm Infants
URL
https://dergipark.org.tr/en/pub/clinexphealthsci/issue/35066/389077
Description
Evidence-Based Interventions Supporting Oral Feeding in Preterm Infants

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Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms

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