The Effect of Neonatal Feeding Modalities on Splanchnic Oxygenation

NCT05513495 | Completed

• 1 other identifier: EskisehirOU-OSOnay-1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Retardation; Feeding Patterns; Splanchnic Hypoperfusion

Keywords

fetal superior mesenteric artery; Intrauterine Growth Retardation; drip feeding; intermittent feeding; regional splanchnic saturation; umbilical catheter

Outcome Measures

Primary Outcomes (4)

• Fetal SMA Doppler measurements

  Antenatal SMA doppler measurements such as pulsatility index

  The last ultrasound study within 48 hours prior delivery was used for analysis.

• Daily mean rSO2S&FOE during the first week of life

  Splanchnic saturation and fractional tissue oxygen extractions during the first week of life

  Continuous rSO2S monitoring was carried out during 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).

  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).

• The incidence of feeding intolerance, necrotising enterocolitis and time to full enteral feeding

  These outcome parameters were evaluated during neonatal intensive care stay

  From admission to discharge

Secondary Outcomes (1)

• The relationship between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation.

  Perinatal period (from 48 hours before delivery to first week of life)

Study Arms (2)

Drip Group

ACTIVE COMPARATOR

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.

Other: The effect of drip versus intermittent feeding on splanchnic oxygenation

Intermittent Group

ACTIVE COMPARATOR

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

Other: The effect of drip versus intermittent feeding on splanchnic oxygenation

Interventions

The effect of drip versus intermittent feeding on splanchnic oxygenation OTHER

After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes).

Drip Group; Intermittent Group

Eligibility Criteria

• Age: 1 Minute - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ozge Surmeli Onay: lead
• Eskisehir Osmangazi University: collaborator

Study Sites (1)

Ozge Surmeli Onay

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

• Surmeli Onay O, Velipasaoglu M, Tutal M, Sarilar TD, Cakil Saglik A, Bilgin M, Aydemir O, Barsan Kaya T, Tanir HM, Tekin AN. The effect of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction: a prospective randomized trial. Eur J Pediatr. 2023 Mar;182(3):1317-1328. doi: 10.1007/s00431-023-04810-x. Epub 2023 Jan 13.

  PMID: 36637540 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation; Feeding Behavior

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Ozge Surmeli Onay

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Associate Professor, Section of Neonatology, Department of Pediatrics Faculty of Medicine

Model Details: A single-center, prospective, randomized trial

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

TU (1)