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Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates

Primary Purpose

Apnea Prematurity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
feeding tube insertion
Sponsored by
Max Super Speciality Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Apnea Prematurity focused on measuring nasogastric, orogastric, nutrition, preterm, feeding tube, insertion, episodes, bradycardia, desaturation

Eligibility Criteria

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

Inclusion Criteria:

  • Hemodynamically stable preterm neonates (≤32 weeks gestational age and PMA ≤ 36weeks) not requiring respiratory support (CPAP/Heated humidified high flow oxygen/ Ventilation).

Exclusion Criteria:

  • Babies (> 32 weeks and PMA>36 weeks)
  • Severe congenital malformations, chromosomal abnormalities
  • Baby requiring any respiratory support
  • Sepsis, IVH, NEC or any illness explaining apneas

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Nasogastric

    Orogastric

    Arm Description

    Feeding tube insertion in nasogastric group

    Feeding tube insertion in orogastric group

    Outcomes

    Primary Outcome Measures

    Heart rate and saturation
    frequency of episodes of heart rate <100 and sauration < 85%

    Secondary Outcome Measures

    infant feeding tube
    duration in hours after which it needs to be changed. We want to see whether nasogastric tube remains in situ for longer time or vice versa

    Full Information

    First Posted
    August 2, 2016
    Last Updated
    March 2, 2017
    Sponsor
    Max Super Speciality Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03073993
    Brief Title
    Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates
    Official Title
    Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Max Super Speciality Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Enteral feeding tubes in newborns are used for feeding preterm and low birth weight babies in neonatal intensive care units as they often do not suck effectively owing to lack of coordination between sucking, swallowing and breathing due to neurological immaturity and delayed gastric emptying. The feeding tubes could be inserted by the nasogastric (NG) route or by the orogastric (OG) route. Both routes are used in different Neonatal Intensive Care Units (NICUs). Both methods are associated with different adverse events. Since newborn infants are obligate nose breathers, nasogastric tube (NGT) can lead to partial nasal obstruction which might increase airway resistance and work of breathing although they are easy to secure to the face than orally placed tubes. Orogastric tubes (OGT), on the other hand, may not lead to the potential risk of increased work of breathing associated with NGT but are more frequently malpositioned and can loop inside the mouth. Also there is increased possibility of apnea and bradycardia due to vagal stimulation. Despite so many years of continuing debate, the evidence of superiority of one method over another is not proven. Very few studies have tried to look into this matter and there are no consensus guidelines. This study is being conducted to compare the rate and type of adverse events in OG versus NG feeds in preterm neonates ≤ 32 weeks and postmenstrual age (PMA) ≤ 36 weeks. Preterm neonates born at ≤ 32 weeks with PMA≤ 36 weeks who require feeding tube as a route for enteral feeding once they are out of respiratory support ( i.e ventilation or CPAP) are eligible candidates. Feeding tube insertion episode (FTIE) is defined as episode of insertion of OG or NG tube. FTIE will be randomized into NG or OG routes. Primary outcome is frequency of desaturation and bradycardia in each group.
    Detailed Description
    After written informed consent by either of the parent, preterm neonate (≤32 weeks gestational age and PMA ≤36weeks) fulfilling the inclusion criteria will be enrolled in the study if they require tube feeding. Each episode of insertion of either NGT or OGT will be labelled as Feeding tube insertion episode (FTIE) in the study. Total of 160 FTIE will be done in study period, 80 FTIEs in preterm neonates of <30 weeks gestational age and 80 FTIE in preterm neonates of ≥30 weeks gestational age. The method of FTIE (whether NG or OG) will be randomized into 2 groups by computer generated random sequence in blocks of 4 each. Stratification will be done as per Gestational age< 30 weeks and ≥ 30 weeks. Randomization sequence will be stored in sealed opaque envelope which was kept with one person who will not involved in care of patients. Tube insertion will be done by NICU nursing staff who are already trained and validated in putting tube. Length of NGT/OGT insertion will be calculated by distance from bridge of nose to ear lobe and then from ear lobe to midway between xiphisternum and umbilicus (NEMU method). Correct tube placement will be checked by first aspirating and then pushing in 2 ml air and listening by stethoscope. Each FTIE will be followed till the tube required to be changed for any reason, or tube feeding terminated due to graduation to direct feeds by paladay or breast. If the tube is changed for any reason, the reinsertion of the tube will be taken as a fresh FTIE, and again followed as above. To record adverse events, heart rate and oxygen saturations will be recorded in the monitor till the time tube remained in situ. Bradycardia is defined as Heart rate < 100/min. Desaturation is defined as SpO2 < 85%. Alarms on the multifunction monitors (Philips MP 20 Neonatal) will be set with lower limit of Heart rate as 100/min and lower limit of saturation as 85%. Episodes will be recorded on a proforma lying at bedside by the duty nurse on the data collection form which include demographic parameters notably name, age, sex, IP No, gestational age at birth in weeks+ days, PMA at enrollment (weeks+ days), method of feeding (OG or NG) along with clinical parameters in the form of desaturation episodes/hr and bradycardia episodes/hr. If a tube remained in situ for more than 24 hours, a new sheet will be taken. Each time monitor give alarm for desaturation and/ or bradycardia, nurse will check the baby and monitor. If the waveform showed regular trend and probe is attached properly to baby, episode will be recorded. Since the duration of NG and OG tubes may vary, the number of episodes of bradycardia and /or desaturation episodes/hr will be compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apnea Prematurity
    Keywords
    nasogastric, orogastric, nutrition, preterm, feeding tube, insertion, episodes, bradycardia, desaturation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nasogastric
    Arm Type
    Active Comparator
    Arm Description
    Feeding tube insertion in nasogastric group
    Arm Title
    Orogastric
    Arm Type
    Active Comparator
    Arm Description
    Feeding tube insertion in orogastric group
    Intervention Type
    Procedure
    Intervention Name(s)
    feeding tube insertion
    Intervention Description
    Feeding tube was inserted in hemodynamically stable babies for purpose of feeding
    Primary Outcome Measure Information:
    Title
    Heart rate and saturation
    Description
    frequency of episodes of heart rate <100 and sauration < 85%
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    infant feeding tube
    Description
    duration in hours after which it needs to be changed. We want to see whether nasogastric tube remains in situ for longer time or vice versa
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Weeks
    Maximum Age & Unit of Time
    32 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hemodynamically stable preterm neonates (≤32 weeks gestational age and PMA ≤ 36weeks) not requiring respiratory support (CPAP/Heated humidified high flow oxygen/ Ventilation). Exclusion Criteria: Babies (> 32 weeks and PMA>36 weeks) Severe congenital malformations, chromosomal abnormalities Baby requiring any respiratory support Sepsis, IVH, NEC or any illness explaining apneas
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Naveen P Gupta, MD, DNB
    Organizational Affiliation
    Consultant Neonatologist
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20234138
    Citation
    Bohnhorst B, Cech K, Peter C, Doerdelmann M. Oral versus nasal route for placing feeding tubes: no effect on hypoxemia and bradycardia in infants with apnea of prematurity. Neonatology. 2010;98(2):143-9. doi: 10.1159/000279617. Epub 2010 Mar 16.
    Results Reference
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    Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates

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