Apnea PrematurityNCT03073993
Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates
A study testing feeding tube insertion in people with Apnea Prematurity, run by Max Super Speciality Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Apnea Prematurity
- What is being tested?
- feeding tube insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hemodynamically stable preterm neonates (≤32 weeks gestational age and PMA ≤ 36weeks) not requiring respiratory support (CPAP/Heated humidified high flow oxygen/ Ventilation).
Who cannot join
- 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
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Apnea Prematurity
- Being tested
- feeding tube insertion
- Keywords
- nasogastric, orogastric, nutrition, preterm, feeding tube, insertion, episodes, bradycardia, desaturation
- Medical subject headings
- Premature Birth, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feeding tube insertionProcedure or surgery
Feeding tube was inserted in hemodynamically stable babies for purpose of feeding
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric | Active comparator | Feeding tube insertion in nasogastric group Receives: Procedure: feeding tube insertion |
| Orogastric | Active comparator | Feeding tube insertion in orogastric group Receives: Procedure: feeding tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate and saturation
frequency of episodes of heart rate <100 and sauration < 85%
Measured: 48 hours
Secondary outcomes (1)
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apnea PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Super Speciality Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SYED AHMAD ZIA, Max Super Speciality Hospital
- Investigators
- Naveen P Gupta, MD, DNB, Study director, Consultant Neonatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073993
- Sponsor's protocol ID
- NGOG
- Status last verified
- Mar 2017
- First submitted
- 2 Aug 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20234138
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates
- ClinicalTrials.gov ID
- NCT03073993
- Acronym / sponsor ID
- NGOG
- Conditions
- Apnea Prematurity
- Keywords
- nasogastric, orogastric, nutrition, preterm, feeding tube, insertion, episodes, bradycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Max Super Speciality HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasogastric | Active comparator | Procedure: feeding tube insertionFeeding tube insertion in nasogastric group |
| Orogastric | Active comparator | Procedure: feeding tube insertionFeeding tube insertion in orogastric group |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hemodynamically stable preterm neonates (≤32 weeks gestational age and PMA ≤ 36weeks) not requiring respiratory support (CPAP/Heated humidified high flow oxygen/ Ventilation).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| feeding tube insertionFeeding tube was inserted in hemodynamically stable babies for purpose of feeding | Procedure or surgery | Nasogastric, Orogastric |
Primary outcome
Heart rate and saturation
Time frame: 48 hours
frequency of episodes of heart rate <100 and sauration < 85%
1 secondary outcome
infant feeding tube
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Background: PubMed 20234138Bohnhorst 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.
- Individual participant dataSharing planned: No
Related trials for Apnea Prematurity
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
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Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
RecruitingObservational study
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Premature Birth, Asthma in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen P Gupta, MD, DNB study director
Consultant Neonatologist
Questions about this trial
What is this clinical trial studying?
A study testing feeding tube insertion in people with Apnea Prematurity, run by Max Super Speciality Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate and saturation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.