Maternal Role in Oral Feed Establishment in Preterm Neonates

Not Applicable

Completed

Conditions: Preterm Birth
Swallowing Disorder
Tube Feeding
Maternal Care Patterns

Interventions: Other: perioral sensory motor stimulation

Registration Number: NCT05484726

Lead Sponsor: Fatima Memorial Hospital

Brief Summary: Hypothesis

Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

1. Start taking oral feed at the same time as compared to control group

2. Take the same amount of milk at the commencement of oral feeding

3. Take milk with equal efficiency

4. Not face more adverse effects

Detailed Description: Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective

1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding

2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses

3. Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

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

1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation

2. 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)

3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)

4. 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:

* Level 1: PRO \< 30% and RT \< 1.5 ml/min

* Level 2: PRO \< 30% and RT ≥ 1.5 ml/min

* Level 3: PRO ≥ 30% and RT \< 1.5 ml/min

* Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

All preterm of gestation age 28 to 34weeks
Haemodynamically stable
Established full Gavage feed
No respiratory distress
No need for respiratory support except LFNC
Do not receive any kind of analgesics

Exclusion Criteria

Syndromic babies /genetic disorders
Haemodynamically unstable babies including IVH (grade III & IV), hemodynamically significant PDA on treatment, NEC(stage III)
Major malformations
Cleft lip and palate
Anemia requiring blood transfusion

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group (Group 2)	perioral sensory motor stimulation	All steps will be the same as the intervention group and shall be performed by staff nurses
Intervention group (Group 1)	perioral sensory motor stimulation	* Maternal involvement shall be in three stages for the intervention group as * Observer status * Performing under supervision * Independent * Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes) Intervention group (Group I): by mothers 1. T1: Nurses performing all steps while mother observer status 2. T2: Nurses perform all steps in front of the mother and a pacifier will be offered by the mother 3. D1: Mother performs all steps and oral milk shall be offered by the nurse while the mother observes. 4. D2: Mother performing all steps and offering oral milk while the nurse is supervising 5. D3: Mother performing all steps independently

Primary Outcome Measures

Name	Time	Method
Transition Time to Full Oral Feeding	Expected time of oral feed establishment	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.
Improvement (Change) in Efficiency in Oral Feed Establishment	For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14	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: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min For all neonates, efficacy was measured at 11.00 am and 5.00 pm following sensory motor stimulation for both groups till achievement of full oral feed.
•Adverse Outcome Monitoring	Adverse events were noted on D1, D2,D3,D5,D7 and D14	monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring 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
•Adverse Events Monitoring	Adverse events were noted on D1, D2,D3,D5,D7 and D14	monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring 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

Secondary Outcome Measures

Name	Time	Method
• Total Volume Taken During Each Feeding	It was noted on D1, D2, D3, D5, D7 and D14	It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding
• Volume Taken During the First 5 Min of Feeding (ml) VT5	Volume taken during the first 5 min of feeding (ml) VT5 was measured 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
•Rate of Transfer (RT) ml/Min	RT was measured on D1, D2, D3, D5, D7 and D14	RT is the time taken by neonate to finish oral feed
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed	OT was measured on D1, D2, D3, D5, D7 and D14	trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed	PRO % was measured on D1, D2, D3, D5, D7 and D14	how much amount of milk is taken during first 5 minutes while administering oral feeding
• Neonates Feeding With SSB Coordination	It was measured on D1, D2, D3, D5, D7 and D14	number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB)