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Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effect on Respiratory Morbidity (CONFER)

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ClinicalTrials.gov Identifier: NCT03961139
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:

Chronic Lung Disease (CLD) of Prematurity is a common yet challenging co-morbidity affecting extremely premature newborns. Multifactorial influences leading to this co-morbidity is known and targeted in various research studies. Gastroesophageal reflux (GER) is common among the same cohort of patients. The investigators hypothesize that recurrent milk reflux into the airways of the premature babies worsen the inflammation of premature lungs and is a major contributor of CLD.

The investigators hypothesize that Continuous feeding (CF) minimises GER and micro-aspiration, thereby reducing the incidence and severity of CLD in high-risk infants.

Our aim is to compare the effect of intermittent bolus versus continuous intra-gastric feeding on the incidence and severity of CLD in very low birth weight infants ≤ 1250 grams.


Condition or disease Intervention/treatment Phase
Chronic Lung Disease of Prematurity Bronchopulmonary Dysplasia Other: Method of feeding; continuous feeding OR bolus feeding Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised-controlled trial with 2 parallel groups (1:1 ratio). Control group: intermittent bolus intra-gastric tube feeding (BF), Intervention group: continuous intra-gastric tube feeding (CF). Not blinded.

Stratified randomization along following birth weight groups:

  1. </=750 g
  2. 751 - 1000 g
  3. 1001 -1250 g Method of randomisation: Computer generated randomization codes stored in sealed opaque envelopes.

Intervention started by 72 hours of life (more than trophic feed volume achieved) and continued until an infant reaches a weight of 1.6 kg and is determined by the attending Neonatologist to be ready to commence oral feeding by breast or bottle, or when an infant attains a post-conceptional age of 36 weeks, whichever is earlier.

Continuous fed is delivered through a nasogastric tube by a syringe pump over 3hrs with 1 hour of break - 6 cycles a day. Feed volume, type of feed, feed increment regulated by the clinical team.

Intention to treat analysis.

Masking: None (Open Label)
Masking Description: na. Open label
Primary Purpose: Prevention
Official Title: Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effects on Respiratory Morbidity: A Multicentre Randomised Controlled Clinical Trial
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous feeding (CF)

Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

Feed volume increment per day is as per departmental protocol and same as comparator arm.

Other: Method of feeding; continuous feeding OR bolus feeding

CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.


Active Comparator: Bolus feeding (BF)

Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.

Feed volume increment per day is as per departmental protocol and same as experimental arm.

Other: Method of feeding; continuous feeding OR bolus feeding

CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.





Primary Outcome Measures :
  1. Incidence of BPD [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    BPD as defined by 2001 NICHD criteria

  2. Incidence of Death [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    Death occurring before 36 weeks post menstrual age or 28 days of life


Secondary Outcome Measures :
  1. Invasive Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on invasive ventilation

  2. Any Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on any ventilatory (invasive or non invasive) support

  3. Supplemental Oxygen support [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on supplemental oxygen

  4. Feed tolerance [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Time (days) from randomization to achievement of full feeds (defined as 150ml/Kg/Day)

  5. Weight outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for weight (grams)

  6. Length outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for length (cm)

  7. Head Growth outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for head circumference (cm)



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with a birth weight <1250g and a gestational age of between 24+0 - 33+6 weeks

Exclusion Criteria:

  1. Major congenital malformation
  2. Chromosomal abnormality
  3. 10-minute Apgar score of =3
  4. Not expected to survive beyond 72 hours of age
  5. Bilateral grade 4 intraventricular haemorrhage (IVH)
  6. Did not consent / Consent not available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961139


Contacts
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Contact: Agnihotri Biswas, MRCPCH +65 67725075 biswas_agnihotri@nuhs.edu.sg
Contact: Jiun Lee, MRCPCH +65 67725076 lee_jiun@nuhs.edu.sg

Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Agnihotri Biswas, MRCPCH Senior Consultant Neonatologist, NUH Singapore

Publications:

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03961139     History of Changes
Other Study ID Numbers: 2018/00773
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National University Hospital, Singapore:
Prematurity
Randomised control trial (RCT)
BPD
CLD
continuous feeding

Additional relevant MeSH terms:
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Lung Diseases
Premature Birth
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases