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The Effect of Neonatal Feeding Modalities on Splanchnic Oxygenation

Primary Purpose

Intrauterine Growth Retardation, Feeding Patterns, Splanchnic Hypoperfusion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The effect of drip versus intermittent feeding on splanchnic oxygenation
Sponsored by
Ozge Surmeli Onay
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intrauterine Growth Retardation focused on measuring fetal superior mesenteric artery, Intrauterine Growth Retardation, drip feeding, intermittent feeding, regional splanchnic saturation, umbilical catheter

Eligibility Criteria

1 Minute - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Doppler measurements must be performed in fetuses with IUGR
  • Preterm infants (GA<37 weeks) with IUGR who were evaluated by Doppler ultrasound were eligible for the study
  • These preterm infants must have no enteral nutrition prior to enrolment.

Exclusion Criteria:

  • Chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia)
  • Inherited metabolic diseases
  • Hydrops fetalis
  • TORCH infection
  • Multiorgan failure
  • Infants with spontaneous intestinal perforation
  • Infants with skin lesions at the site of sensor placement
  • Infants who were hospitalized for shorter than 7 days because of discharge or death

Sites / Locations

  • Ozge Surmeli Onay

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Drip Group

Intermittent Group

Arm Description

Each infant received the same amount of feed via continuous administration for 3 hours, and subsequent feeding resumed 1 hour after the end of continuous feeding. All of the infants were fed through an orogastric tube that was attached to a syringe infusion pump for continuous feeding. Once a full enteral feed of 120 mL/kg/day was achieved, the drip feeding was stopped.

Every 3 hours (×8/day), each infant received a 10-minute gravity bolus of milk/preterm formula via orogastric tube.

Outcomes

Primary Outcome Measures

Fetal SMA Doppler measurements
Antenatal SMA doppler measurements such as pulsatility index
Daily mean rSO2S&FOE during the first week of life
Splanchnic saturation and fractional tissue oxygen extractions during the first week of life
Pre-prandial and post-prandial rSO2S&FOE
Splanchnic saturation and fractional tissue oxygen extractions at the 7th day of life related to feeding modalities (drip vs intermittent feeding).
The incidence of feeding intolerance, necrotising enterocolitis and time to full enteral feeding
These outcome parameters were evaluated during neonatal intensive care stay

Secondary Outcome Measures

The relationship between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation.
The relation between fetal SMA doppler parameters and regional splanchnic saturation measurements

Full Information

First Posted
August 22, 2022
Last Updated
August 23, 2022
Sponsor
Ozge Surmeli Onay
Collaborators
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05513495
Brief Title
The Effect of Neonatal Feeding Modalities on Splanchnic Oxygenation
Official Title
The Effect of Drip Versus Intermittent Feeding on Splanchnic Oxygenation in Preterm Infants With Intrauterine Growth Retardation: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozge Surmeli Onay
Collaborators
Eskisehir Osmangazi University

4. Oversight

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

5. Study Description

Brief Summary
OBJECTIVES: The main purpose of this study was to evaluate the impact of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction (IUGR). The second objective was to assess the relationship between fetal splanchnic circulation parameters and splanchnic oxygenation during the first week of life. METHODS: A single-center, prospective, randomized study with 51 fetuses/infants was conducted. Fetal Doppler measurements including umbilical artery, middle cerebral artery, and superior mesenteric artery (SMA) were recorded in IUGR fetuses. After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes). Continuous regional splanchnic saturation (rSO2S) monitoring was carried out during first week of life, simultaneously with continuous oxygen arterial saturation (SaO2) monitoring and the infants' fractional oxygen extractions (FOE) were calculated. These parameters were evaluated as means on a daily basis for the first week of life, as well as pre-prandial and post-prandial measurements on the seventh day. RESULTS: Fetal Doppler flow velocimetry disturbances were present in 72.5% of the study cohort. The Drip (26 infants) and Intermittent (25 infants) groups were similar in demographic and clinical characteristics, as well as the prevalence of feeding intolerance and necrotizing enterocolitis. During the first week of life, there was no difference in daily mean rSO2S and FOE values between the Drip and Intermittent groups, whereas unfed infants had mostly lower rSO2S values. Pre-prandial and post-prandial rSO2S values remained stable in both groups. Also, no association was detected between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation. RSO2S values were strongly correlated to gestational age and birth weight. During the whole week, except for the first two days, infants with umbilical catheters had significantly lower rSO2S values than infants without. CONCLUSIONS: Our data suggests that the key factor in splanchnic oxygenation is feeding, not the feeding modality. In addition, the umbilical vein catheter had a negative impact on splanchnic oxygenation.
Detailed Description
Study design This single-center prospective randomized study was conducted in a university hospital between 1 January 2019-1 October 2021. This work has been supported by Eskisehir Osmangazi University Scientific Research Projects Coordination Unit under grant number 61690618-604.99-E.61140. This study was conducted in conformity with the principles and regulations of the Helsinki Declaration. The Institutional Ethics Committee approved the study (No: 80558721-050.99-E.105607) and informed consent forms were received from all parents/legal guardians of each fetus/infant before inclusion in the study. Study Cohort The inclusion criteria were that the parents agreed to participate in the study and that Doppler measurements could be performed in fetuses with IUGR and following preterm birth (GA<37 weeks) with no enteral nutrition prior to enrolment. The infants with chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia), inherited metabolic diseases, hydrops fetalis, TORCH infection, multiorgan failure, infants with spontaneous intestinal perforation, infants with skin lesions at the site of sensor placement and infants who were hospitalized shorter than 7 days because of discharge or death were excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Retardation, Feeding Patterns, Splanchnic Hypoperfusion
Keywords
fetal superior mesenteric artery, Intrauterine Growth Retardation, drip feeding, intermittent feeding, regional splanchnic saturation, umbilical catheter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-center, prospective, randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drip Group
Arm Type
Active Comparator
Arm Description
Each infant received the same amount of feed via continuous administration for 3 hours, and subsequent feeding resumed 1 hour after the end of continuous feeding. All of the infants were fed through an orogastric tube that was attached to a syringe infusion pump for continuous feeding. Once a full enteral feed of 120 mL/kg/day was achieved, the drip feeding was stopped.
Arm Title
Intermittent Group
Arm Type
Active Comparator
Arm Description
Every 3 hours (×8/day), each infant received a 10-minute gravity bolus of milk/preterm formula via orogastric tube.
Intervention Type
Other
Intervention Name(s)
The effect of drip versus intermittent feeding on splanchnic oxygenation
Intervention Description
After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes).
Primary Outcome Measure Information:
Title
Fetal SMA Doppler measurements
Description
Antenatal SMA doppler measurements such as pulsatility index
Time Frame
The last ultrasound study within 48 hours prior delivery was used for analysis.
Title
Daily mean rSO2S&FOE during the first week of life
Description
Splanchnic saturation and fractional tissue oxygen extractions during the first week of life
Time Frame
Continuous rSO2S monitoring was carried out during first week of life.
Title
Pre-prandial and post-prandial rSO2S&FOE
Description
Splanchnic saturation and fractional tissue oxygen extractions at the 7th day of life related to feeding modalities (drip vs intermittent feeding).
Time Frame
During seventh day of life, the machine's marking button was pressed when the feeding began (09:00 am and 21:00 pm feeding practices were evaluated for each infant).
Title
The incidence of feeding intolerance, necrotising enterocolitis and time to full enteral feeding
Description
These outcome parameters were evaluated during neonatal intensive care stay
Time Frame
From admission to discharge
Secondary Outcome Measure Information:
Title
The relationship between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation.
Description
The relation between fetal SMA doppler parameters and regional splanchnic saturation measurements
Time Frame
Perinatal period (from 48 hours before delivery to first week of life)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Doppler measurements must be performed in fetuses with IUGR Preterm infants (GA<37 weeks) with IUGR who were evaluated by Doppler ultrasound were eligible for the study These preterm infants must have no enteral nutrition prior to enrolment. Exclusion Criteria: Chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia) Inherited metabolic diseases Hydrops fetalis TORCH infection Multiorgan failure Infants with spontaneous intestinal perforation Infants with skin lesions at the site of sensor placement Infants who were hospitalized for shorter than 7 days because of discharge or death
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Surmeli Onay
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozge Surmeli Onay
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

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The Effect of Neonatal Feeding Modalities on Splanchnic Oxygenation

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