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Hypothesis
Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective
1. Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects
Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details
Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation
Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study)
Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)
Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes
Total volume prescribed (ml)
Total volume has taken during feeding (ml)
Volume has taken during the first 5 min of feeding (ml)
Duration of oral feeding (min)
Overall transfer (OT %) volume taken/total volume prescribed
Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed
Rate of transfer (RT) ml/min
SSB (Suck Swallow Breaths) coordination
Adverse events (cough, fatigue)
According to this oral feeding ability can be classified into four levels depending upon the level of maturity in ascending order as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (Group 1) | Experimental |
Intervention group (Group I): by mothers
|
|
| Control group (Group 2) | Sham Comparator | All steps will be the same as the intervention group and shall be performed by staff nurses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perioral sensory motor stimulation | Other | Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
| Measure | Description | Time Frame |
|---|---|---|
| Transition Time to Full Oral Feeding | Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day. | Expected time of oral feed establishment |
| Improvement (Change) in Efficiency in Oral Feed Establishment | According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows:
| For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14 |
| •Adverse Outcome Monitoring | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with
| Adverse events were noted on D1, D2,D3,D5,D7 and D14 |
| •Adverse Events Monitoring | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with
|
| Measure | Description | Time Frame |
|---|---|---|
| • Total Volume Taken During Each Feeding | It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding | It was noted on D1, D2, D3, D5, D7 and D14 |
| • Volume Taken During the First 5 Min of Feeding (ml) VT5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafia Gul, FCPS (Neo) | Fatima Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rafia Gul | Lahore | Shadman | 54610 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32903261 | Background | da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020. | |
| 29190845 | Background | Murthy SV, Funderburk A, Abraham S, Epstein M, DiPalma J, Aghai ZH. Nasogastric Feeding Tubes May Not Contribute to Gastroesophageal Reflux in Preterm Infants. Am J Perinatol. 2018 Jun;35(7):643-647. doi: 10.1055/s-0037-1608875. Epub 2017 Nov 30. |
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After approval from the publishing journal once the study has been completed
1 year after the study's publication for 3 months
on request to corresponding author
Not provided
Out of 142 eligible neonates, study was started with 130 as 65 in each group. Twelve neonates were excluded as 2 mothers experienced serious postnatal complications, 1 instance of parental refusal after initial participation, 1 case with incomplete data, and 8 others.
Out of 65 neonates in each group, in 49 from intervention group and 48 from control group, sensory motor stimulation could be performed per protocol as 33 total neonates were excluded and details have been mentioned in table.
The study period spans 16 months (March 2022 - July 2023), in the department of Neonatology, Fatima Memorial Hospital, Lahore. All preterm of gestation age 28 to 34 weeks, admitted to NICU during the study period after seeking consent from parents or guardians were enrolled. All neonates having major anomalies incompatible with life, cleft lip and palate, genetic disorders, IVH (grade III & IV), HsPDA, hemodynamic instability, NEC (stage II & III) or anemia requiring transfusion were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group (Group 1) |
Intervention group (Group I): by mothers
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
| FG001 | Control Group (Group 2) | All steps were the same as the intervention group and were performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (Group 1) | Maternal involvement was done in three stages for the intervention group as
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | maternal age at time of delivery measured as years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Transition Time to Full Oral Feeding | Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day. | Posted | Median | Inter-Quartile Range | days | Expected time of oral feed establishment |
|
For every neonate adverse events were monitored from first day (D1) of perioral sensory - motor stimulation to day of full oral feed establishment expected by Day 14
Only those neonates were enrolled in study who were stable enough to tolerate the procedure of sensory motor stimulation and feeding.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (Group 1) |
Intervention group (Group I): by mothers
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-life threatening adverse events | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment | cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of >90% at room air |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor Dr Rafia Gul | Fatima Memorial Hospital Shadman Lahore | 00923064620027 | docrafiagul@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 21, 2024 | Apr 23, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Maternal involvement in perioral sensory-motor stimulation be in three stages
Intervention period: 5 days as
Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs.
Two groups
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The mothers, medical staff involved in general care, nursing staff involved in the intervention, and doctors conducting the assessment of oral feeding skills (OFS) were all blinded to allocation. The nursing staff was informed at the time of intervention that participating infants would receive either sensory motor stimulation or sham oral stimulation depending on group allocation.
|
| Adverse events were noted on D1, D2,D3,D5,D7 and D14 |
during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes
| Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14 |
| •Rate of Transfer (RT) ml/Min | RT is the time taken by neonate to finish oral feed | RT was measured on D1, D2, D3, D5, D7 and D14 |
| • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed | OT was measured on D1, D2, D3, D5, D7 and D14 |
| • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | how much amount of milk is taken during first 5 minutes while administering oral feeding | PRO % was measured on D1, D2, D3, D5, D7 and D14 |
| • Neonates Feeding With SSB Coordination | number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB) | It was measured on D1, D2, D3, D5, D7 and D14 |
| 22254018 | Background | Rogers SP, Hicks PD, Hamzo M, Veit LE, Abrams SA. Continuous feedings of fortified human milk lead to nutrient losses of fat, calcium and phosphorous. Nutrients. 2010 Mar;2(3):230-40. doi: 10.3390/nu2030240. Epub 2010 Feb 26. |
| 31366911 | Background | Viswanathan S, Jadcherla S. Transitioning from gavage to full oral feeds in premature infants: When should we discontinue the nasogastric tube? J Perinatol. 2019 Sep;39(9):1257-1262. doi: 10.1038/s41372-019-0446-2. Epub 2019 Jul 31. |
| 27644167 | Background | Greene Z, O'Donnell CP, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009720. doi: 10.1002/14651858.CD009720.pub2. |
| Background | 6. Maltese A, Gallai B, Marotta R, Lavano F, Lavano S, Tripi G. The synactive theory of development: the keyword for neurodevelopmental disorders. Acta Medica Mediterranea, 2017, 33: 1257-63 |
| 30817764 | Background | Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019. |
| 22675368 | Background | Bertoncelli N, Cuomo G, Cattani S, Mazzi C, Pugliese M, Coccolini E, Zagni P, Mordini B, Ferrari F. Oral feeding competences of healthy preterm infants: a review. Int J Pediatr. 2012;2012:896257. doi: 10.1155/2012/896257. Epub 2012 May 17. |
| 12205253 | Background | Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. doi: 10.1542/peds.110.3.517. |
| 9108854 | Background | Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr. 1997 Apr;130(4):561-9. doi: 10.1016/s0022-3476(97)70240-3. |
| 30898170 | Background | Sarin E, Maria A. Acceptability of a family-centered newborn care model among providers and receivers of care in a Public Health Setting: a qualitative study from India. BMC Health Serv Res. 2019 Mar 21;19(1):184. doi: 10.1186/s12913-019-4017-1. |
| Background | 13. Fonseca SA, Silveira AO, Franzoi MAH, Motta E. Family centered-care at the neonatal intensive care unit (NICU): nurses' experiences. EnfermerÃa: Cuidados Humanizados. 2020; 9(2): 170-190 |
| 30851536 | Background | Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5. |
| 21707601 | Background | Fucile S, Gisel EG, McFarland DH, Lau C. Oral and non-oral sensorimotor interventions enhance oral feeding performance in preterm infants. Dev Med Child Neurol. 2011 Sep;53(9):829-835. doi: 10.1111/j.1469-8749.2011.04023.x. Epub 2011 Jun 27. |
| 21212698 | Background | Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5. |
| 34182577 | Background | Majoli M, De Angelis LC, Panella M, Calevo MG, Serveli S, Knoll BL, Ramenghi LA. Parent-Administered Oral Stimulation in Preterm Infants: A Randomized, Controlled, Open-Label Pilot Study. Am J Perinatol. 2023 Jun;40(8):845-850. doi: 10.1055/s-0041-1731452. Epub 2021 Jun 28. |
| HsPDA requiring antifailure therapy |
|
| continued need of mechanical ventilation |
|
| Withdrawal by Subject |
|
| IVH (G III & IV) |
|
| NEC (stage II & III) |
|
| BG001 | Control Group (Group 2) | All steps were the same as the intervention group and were performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex/Gender, Customized | all mothers were female | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Maternal education | Count of Participants | Participants |
|
| mothers with previous preterm neonates | Count of Participants | Participants |
|
| Maternal Job status | Count of Participants | Participants |
|
| hypertensive disorder of pregnancy | maternal record of blood pressure during pregnancy was used to diagnose pregnancy induced hypertension | Count of Participants | Participants |
|
| Gestational diabetes mellitus | diabetes mellitus was diagnosed in pregnancy by measuring blood sugar level by 20 weeks of gestation or later | Count of Participants | Participants |
|
| anemia of pregnancy | Maternal hemoglobin of < 10 mg/dl was labelled as anemia of pregnancy | Count of Participants | Participants |
|
| Gravidity | Count of Participants | Participants |
|
| neonatal gender (male) | Count of Participants | Participants |
|
| Gestation age at delivery | Median | Inter-Quartile Range | weeks |
|
| Mode of delivery (SVD) | Count of Participants | Participants |
|
| Birth weight | Median | Inter-Quartile Range | Kg |
|
| Weight for gestational age | neonatal weight was plotted for gestation age on gender specific growth chart to determine weight for gestation age | Count of Participants | Participants |
|
| Place of birth (Inborn) | In born were all those neonates who were born in our own hospital | Count of Participants | Participants |
|
| Required Invasive mechanical ventilation (IMV) | Count of Participants | Participants |
|
| Duration of IMV | the number of neonates receiving IMV | Median | Inter-Quartile Range | days |
|
| Required non invasive ventilation (NIV) | all neonates had respiratory failure and were spontaneously breathing require non invasive ventilation (NIV) | Count of Participants | Participants |
|
| Duration of non invasive ventilation (NIV) | for only those neonates who received non invasive ventilation | Only those neonates who received non invasive ventilation (NIV) | Median | Inter-Quartile Range | days |
|
| Required low flow nasal cannula therapy (LFNC) | All neonates with type 1 respiratory failure requiring oxygen only to maintain their oxygen saturation | Count of Participants | Participants |
|
| Duration of LFNC | only those neonates who required low flow nasal cannula therapy (LFNC) | Only those neonates were analysed who required LFNC | Median | Inter-Quartile Range | days |
|
| Apnea | Apnea was diagnosed on basis of breath holding spells for > 20 second with or without bradycardia | Count of Participants | Participants |
|
| Respiratory distress syndrome (RDS) | Respiratory distress syndrome (RDS) was diagnosed on clinical and radiological features of reticulo-nodular shadowing | Count of Participants | Participants |
|
| Caffeine | Use of prophylactic caffeine therapy as yes or now. It was given to all neonates < 32 weeks of gestation age as started on first day of life to avoid apnea of prematurity. | Count of Participants | Participants |
|
| Hemodynamically significant patent ductus arteriosus (HsPDA) | Count of Participants | Participants |
|
| Necrotizing enterocolitis (NEC) | Count of Participants | Participants |
|
| Feeding intolerence | Count of Participants | Participants |
|
| Sepsis | Count of Participants | Participants |
|
| Seizures | Count of Participants | Participants |
|
| Post menstural age (PMA) at enrollment | Median | Inter-Quartile Range | weeks |
|
| Chronological age (ChA) at enrollment | Median | Inter-Quartile Range | days |
|
| Time to full gavage feed | Median | Inter-Quartile Range | days |
|
| Discharge weight | Median | Inter-Quartile Range | Kg |
|
| Weight at enrollment | Median | Inter-Quartile Range | Kg |
|
| Duration of stay in NICU | Median | Inter-Quartile Range | days |
|
| OG001 | Control Group (Group 2) | All steps were the same as the intervention group and were performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times |
|
|
| Primary | Improvement (Change) in Efficiency in Oral Feed Establishment | According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows:
| neonates were assessed for efficacy of level 4 (L4) on D1, D2,D3,D5,D7 and D14 | Posted | Count of Participants | Participants | For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14 |
|
|
|
| Primary | •Adverse Outcome Monitoring | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with
| All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of >90% at room air | Posted | Count of Participants | Participants | Adverse events were noted on D1, D2,D3,D5,D7 and D14 |
|
|
|
| Secondary | • Total Volume Taken During Each Feeding | It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding | Posted | Median | Inter-Quartile Range | ml | It was noted on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Secondary | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes | Posted | Median | Inter-Quartile Range | ml | Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Secondary | •Rate of Transfer (RT) ml/Min | RT is the time taken by neonate to finish oral feed | Posted | Median | Inter-Quartile Range | ml/min | RT was measured on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Secondary | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed | Posted | Median | Inter-Quartile Range | percentage of volume taken/total volume | OT was measured on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Secondary | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | how much amount of milk is taken during first 5 minutes while administering oral feeding | Posted | Median | Inter-Quartile Range | percentage of volume taken during the fi | PRO % was measured on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Secondary | • Neonates Feeding With SSB Coordination | number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB) | Posted | Count of Participants | Participants | It was measured on D1, D2, D3, D5, D7 and D14 |
|
|
|
| Primary | •Adverse Events Monitoring | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with
| All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of >90% at room air | Posted | Count of Participants | Participants | Adverse events were noted on D1, D2,D3,D5,D7 and D14 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 16 |
| 49 |
| EG001 | Control Group (Group 2) | All steps will be the same as the intervention group and shall be performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times | 0 | 48 | 0 | 48 | 19 | 48 |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| L4 efficacy by D7 |
|
| L4 efficacy by D14 |
|
| Adverse events D3 |
|
| Averse events D5 |
|
| Adverse events D7 & 14 |
|
| Oral feed volume/feed on D3 |
|
| Oral feed volume/feed on D5 |
|
| Oral feed volume/feed on D7 |
|
| Oral feed volume/feed on D14 |
|
| VT5 on D3 |
|
| VT5 on D5 |
|
| VT5 on D7 |
|
| VT5 on D14 |
|
| RT on D3 |
|
| RT on D5 |
|
| RT on D7 |
|
| RT on D14 |
|
| OT on D3 |
|
| OT on D5 |
|
| OT on D7 |
|
| OT on D14 |
|
| PRO on D3 |
|
| PRO on D5 |
|
| PRO on D7 |
|
| PRO on D14 |
|
| SSB on D3 |
|
| SSB on D5 |
|
| SSB on D7 |
|
| SSB on D14 |
|
| Adverse events D3 |
|
| Averse events D5 |
|
| Adverse events D7 & 14 |
|