Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03073993
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2016-08-02
Brief Title:
Nasogastric Versus Orogastric Route of Feeding in Preterm 32 Weeks Neonates
Sponsor:
Max Super Speciality Hospital
Organization:
Max Super Speciality Hospital
Study Overview
Official Title:
Nasogastric Versus Orogastric Route of Feeding in Preterm 32 Weeks Neonates
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 NGTOGT 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 100min 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 100min 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 episodeshr and bradycardia episodeshr
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 episodeshr will be compared
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 NGTOGT 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 100min 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 100min 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 episodeshr and bradycardia episodeshr
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 episodeshr will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None